SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF: a Randomized Control Trial
Phase: NA
Conditions: Infertility
Sponsor: University of North Carolina, Chapel Hill

1 
 
 
 
C o m pl et e Titl e:  Ev al u ati o n of Ut eri n e C a vit y U si n g O ffic e H yst er osc o p y V ers us S ali n e I nf usi o n S o n o gr a p h y: A 
R a n d o miz e d C o ntr ol l e d Tri al    
 
Dr u g or D e vic e N a m e(s):  N/ A   
F D A I N D/I D E (if a p plic a bl e):  
S p o ns or:  N/ A  
Pr ot oc ol D at e:  1 1/ 1 0/ 2 0 1 8  
A m e n d m e nt 1 D at e:  6/ 1 0/ 2 0 1 9  
A m e n d m e nt 2 D at e:  
A m e n d m e nt 3 D at e:  
A m e n d m e nt 4 D at e:  
N C T N u m b er: N C T 0 4 4 1 5 4 8 9  
D oc u m e nt D at e: 0 6/ 1 0/ 2 0 1 9  
 
 
 
 
 
 
St u d y Pri nci p al I n v esti g at or S ar a h M o ust af a  
7 9 2 0 A C C Bl v d # 3 0 0  
R al ei g h, N C 2 7 6 1 7  
P h o n e 8 0 3 -3 7 8 -3 0 0 0  
e m ail: s ar a h _ m o ust af a @ m e d. u nc. e d u 
 
 
 
 
 
 

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P R O T O C OL TI TL E:  Ev al u ati o n of Ut eri n e C a vit y U si n g O ffic e H yst er osc o p y V ers us S ali n e I nf usi o n S o n o gr a p h y: A 
R a n d o miz e d C o ntr ol l e d Tri al 
 
 
 
L e a d I n v esti g at or: 
S ar a h M o ust af a, M. D.  
 U ni v ersit y of N ort h C ar oli n a at C h a p el Hill 
Pr ot oc ol V ersi o n: 2 . 0  
V ersi o n D at e: J u n e 1 0, 2 0 1 9 
 
I c o nfir m t h at I h a v e r e a d t his pr ot oc ol a n d u n d erst a n d it.    
Pri nci p al I n v esti g at or N a m e:   
 
S ar a h M o ust af a  
Pri nci p al I n v esti g at or Si g n at ur e:   
  
  
  
  
  
  
 
D at e:     
  
  
 
J u n e 1 0, 2 0 19 
 
 
 
 
 
 
 
 
 
 
 

3 
 
 
 
 
 
T A BL E O F C O N T E N TS
T A BL E O F C O N T E N TS  
T a bl e of C o nt e nts
T a bl e of C o nt e nts  ................................
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..................... 3  
A b br evi ati o ns a n d D efi niti o ns of T er ms
A b br evi ati o ns a n d D efi niti o ns of T er ms  ................................
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................... 4  
Pr ot oc ol Sy n o psis
Pr ot oc ol Sy n o psis  ................................
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..................... 5  
1  
B A C K G R O U N D  A N D R A TI O N AL E ....................................................................................................................... 8 
2  
S T U D Y O BJ E C TI V ES  ............................................................................................................................................ 9 
3  
I N V ES TI G A TI O N AL PL A N .................................................................................................................................. 1 0  
4  
S T U D Y P R O C E D U R E S  ....................................................................................................................................... 1 0 
5  
S T U D Y E V AL U A TI O NS A N D M E A S U R E M E N TS  ................................................................................................. 1 3  
6  
S T A TI S TI C AL C O N SI D E R A TI O N S  ....................................................................................................................... 1 3  
7  
S T U D Y I N T E R V E N TI O N ( D E VI C E O R O T H E R I N T E R V E N TI O N) .......................................................................... 1 5  
8 
S T U D Y I N T E R V E N TI O N A D MI NIS T R A TI O N  ...................................................................................................... 1 5  
9 
S A F E T Y M A N A G E M E N T  ................................................................................................................................... 1 5  
1 0  D A T A C OLL E C TI O N A N D M A N A G E M E N T  ......................................................................................................... 1 7  
1 1  R E C R UI T M E N T S T R A T E G Y  ............................................................................................................................... 1 7  
1 2 C O N S E N T P R O C E S S .......................................................................................................................................... 1 8  
1 3  P U BLI C A TI O N  ................................................................................................................................................... 1 8  
1 4  R E F E R E N C E S  .................................................................................................................................................... 1 8  
A p p e n dix
A p p e n dix  ................................
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................................ 1 8
1 8  
 
 
 
 
 
 
 
 
 
 
 

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A B B R E VI A TI O N S A N D D E FI NI TI O N S O F T E R M S  
 
 
 
 
A b br e vi ati o n  
D efi niti o n  
SI S  
S ali n e i nf usi o n s o n o gr a p h y  
H S G  
H yst er os al pi n g o gr a m  
O R  
O p er ati n g r o o m  
P M H  
P ast m e dic al hist or y  
P S H  
P ast s ur gic al hist or y  
I V F 
I n Vitr o F ertiliz ati o n 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

5 
 
P R O T O C OL S Y N O P SI S
P R O T O C OL S Y N O P SI S  
St u dy Titl e
St u dy Titl e  
Ev al u ati o n of ut eri n e c a vit y usi n g offic e h yst er osc o p y v ers us s ali n e 
i nf usi o n s o n o gr a p h y: A r a n d o miz e d c o ntr ol tri al 
F u n d er
F u n d er  
N/ A  
Cli nic al P h as e
Cli nic al P h as e  
N/ A  
St u dy R ati o n al e
St u dy R ati o n al e  
S ali n e i nf usi o n s o n o gr a p h y ( SI S ) a n d h yst er osc o p y ar e c o m m o nl y 
e m pl o y e d m et h o ds f or ut eri n e c a vit y e v al u ati o n. SI S is oft e n p erf or m e d 
as a scr e e ni n g t o ol  i n t h e offic e f or ut eri n e e v al u ati o n si nc e it is str ai g ht-
f or w ar d t o p erf or m, w ell-t ol er at e d h as l o w o v er h e a d c ost.  If ut eri n e 
p at h ol o g y is s us p ect e d o n SI S, s u bs e q u e nt h yst er osc o p y is t y pic all y 
p erf or m e d i n t h e o p er ati n g r o o m. H yst er osc o p y r e m ai ns t h e g ol d 
st a n d ar d f or di a g n osis of i ntr a-ut eri n e p at h ol o g y a n d off ers t h e 
o p p ort u nit y f or i nt er v e nti o n at ti m e of di a g n osis , b ut oft e n is n ot us e d as 
t h e i niti al scr e e ni n g t o ol b ec a us e of pr o vi d er c o nc er ns a b o ut i n- offic e 
t ol er a bilit y, e q ui p m e nt c ost a n d m ai nt e n a nc e. T ec h n ol o g y 
a d v a nc e m e nts , h o w e v er, h as i ntr o d uc e d aff or d a bl e, dis p os a bl e, s m all 
c ali b er h yst er osc o p es wit h a n o p er ati v e c h a n n el t o m a k e  it p ossi bl e f or 
t his t y p e of ass ess m e nt t o b e p erf or m e d i n t h e offic e s etti n g wit h t h e 
a d diti o n of a ‘s e e a n d tr e at’ m o d alit y. If us e d t o p erf or m i niti al ut eri n e 
c a vit y e v al u ati o n, h yst er osc o p y m a y off er ex p e dit e d di a g n osis, 
tr e at m e nt, a n d a v oi d a nc e of g e n er al a n est h esi a. If s u p eri or s p ecificit y is 
d e m o nstr at e d, it m a y als o l o w er t h e f als e p ositi v e r at e, pr e v e nti n g 
u n n ec ess ar y d el a ys t o a p ati e nt’s pr oj ect e d tr e at m e nt pl a n, a n d 
u n n ec ess ar y ex p os ur e t o a n est h esi a ris ks. T o d at e, n o r a n d o miz e d 
c o ntr ol tri als h a v e c o m p ar e d t h e s atisf acti o n of p ati e nts a n d pr o vi d ers t o 
s ali n e i nf usi o n s o n o gr a p h y v ers us offic e h yst er osc o p y wit h o ut a n est h esi a 
i n i niti al c a vit y e v al u ati o n wit h t h e a bilit y t o i m m e di at el y  a d dr ess i ntr a -
ut eri n e p at h ol o g y . 
 
St u d y O bj ecti v e(s)  
1.  C o m p ar e  pr o vi d er  a n d  p ati e nt  s atisf acti o n b et w e e n  SI S  a n d  offic e  
h yst er osc o p y  
2.  R e p ort  o n  c a p a bilit y of  offic e  h yst er osc o p y  t o a d e q u at el y  tr e at 
ut eri n e  p at h ol o g y  a n d  a v oi d  o p er ati n g r o o m m a n a g e m e nt  
3.  R e p ort  o n  i nci d e nc e of  d el a y of  f ertilit y tr e at m e nt i n e ac h  gr o u p  
 
T est Articl e(s)
T est Articl e(s)  
(If A p plic a bl e) 
N/ A  
St u dy D esi g n
St u dy D esi g n  
 
T his is a r a n d o miz e d c o ntr ol tri al. P ati e nts will b e i d e ntifi e d at ti m e of 
t h eir d ecisi o n t o u n d er g o i n-vitr o f ertiliz ati o n , as all p ati e nts wit h t his 
tr e at m e nt pl a n u n d er g o a c a vit y e v al u ati o n pri or t o i niti ati o n of f ertilit y 
tr e at m e nt.   
Aft er o bt ai ni n g i nf or m e d c o ns e nt, p ati e nts will b e r a n d o miz e d t o eit h er 
t h e c o ntr ol ar m wit h tr a diti o n al SI S, or t h e i nt er v e nti o n ar m, usi n g offic e 
h yst er osc o p y. Bl oc k e d r a n d o miz ati o n will b e i nc or p or at e d.  

6 
 
 
P ati e nts w h o d e m o nstr at e p at h ol o g y o n SI S will b e sc h e d ul e d f or 
o p er ati v e h yst er osc o p y i n t h e o p er ati n g r o o m at a l at er d at e as s o o n as 
c a n b e sc h e d ul e d.  
 
P ati e nts w h o d e m o nstr at e  p at h ol o g y  i ncl u di n g p ol y ps or mil d a d h esi v e 
dis e as e  o n offic e h yst er osc o p y will h a v e att e m pt e d i nt er v e nti o n at t h e 
ti m e of i niti al pr oc e d ur e a n d/ or will b e t a k e n t o t h e O R wit h f ail ur e t o 
c o m pl et e t h e d esir e d i nt er v e nti o n or if si g nific a nt p at h ol o g y is 
e nc o u nt er e d ( m y o m as, s e v er e a d h esi v e dis e as e) .  
 
P ati e nt a n d pr o vi d er s atisf ac ti o n will b e ass ess e d t h o u g h q u esti o n n air es 
a d mi nist er e d aft er e ac h pr oc e d ur e. A st atistic al c o m p aris o n of p ati e nts 
r e q uiri n g s u bs e q u e nt pr oc e d ur e i n t h e o p er ati n g r o o m i n e ac h gr o u p will 
als o b e ass ess e d o n i nt e nti o n t o tr e at b asis.  
S u bj ect P o p ul ati o n
S u bj ect P o p ul ati o n  
k ek ey crit eri a f or I ncl usi o n 
y crit eri a f or I ncl usi o n 
a n d Excl usi o n:
a n d Excl usi o n:  
I ncl usi o n Crit eri a 
1.  W o m e n a g e d 1 8 – 5 0  
2.  P ati e nts u n d er g oi n g r o uti n e c a vit y e v al u ati o n f or pl a n n e d i n 
vitr o -f ertiliz ati o n c ycl es  
Excl usi o n Crit eri a  
1.  Cli nic al or r a di ol o gic s us pici o n of  i ntr a ut eri n e p at h ol o g y i ncl u di n g 
m y o m as, s e v er e i ntr a ut eri n e a d h esi o ns or r et ai n e d pr o d ucts of 
c o nc e pti o n 
2.  T h os e wit h m e dic al crit eri a n ot s uit a bl e offic e h yst er osc o p y  d u e 
t o r e q uir e m e nt of a d v a nc e d t o ols or pr e p ar ati o n n ot a v ail a bl e i n 
t h e offic e s uc h as hist or y of bl e e di n g dis or d er or m e dic al c o-
m or bi dit y  
3.  Pr e g n a nc y  
N u m b er of S u bj ects 
N u m b er of S u bj ects  
 
6 0 s u bj ects. P o w er a n al ysis r e q uir es a mi ni m u m of 2 5 i n e ac h gr o u p t o 
d et ect a l ar g e eff ect siz e diff er e nc e i n s atisf acti o n r at e. A n a d diti o n al 5 
s u bj ects i n e ac h gr o u p, f or a t ot al of 3 0, t o acc o u nt f or u p t o 2 0 % dr o p 
o ut r at e.  
St u dy D ur ati o n
St u dy D ur ati o n  
E ac h s u bj ect’s p artici p ati o n will l ast f or t h e d ur ati o n of t h eir ut eri n e 
c a vit y e v al u ati o n a n d tr e at m e nt  of a n y p at h ol o gic fi n di n gs  a n d 
s u bs e q u e nt q u esti o n n air e. 
R ecr uit m e nt is ex p ect e d t o l ast f or o n e y e ar wit h t h e e ntir e st u d y 
ex p ect e d t o l ast t w o y e ars.  
St u dy P h as es
St u dy P h as es  
Scr e e ni n g
Scr e e ni n g  
St u dy Tr e at m e nt
St u dy Tr e at m e nt  
F oll o w
F oll o w -U p 
U p   
 ( 1) Scr e e ni n g : scr e e ni n g f or eli gi bilit y a n d o bt ai ni n g c o ns e nt (2)  
I nt er v e nti o n: c o m pl eti o n of eit h er SI S or offic e h yst er osc o p y a n d  
( 3) F oll o w u p : p ost-pr oc e d ur e q u esti o n n air e, o utc o m e of a n y s u bs e q u e nt 
s ur gic al pr oc e d ur es 
Effic acy Ev al u ati o ns
Effic acy Ev al u ati o ns  
Ev al u ati o n of s atisf acti o n sc or es, a bilit y t o c o m pl et e di a g n ostic a n d 
t h er a p e utic g o als, a n d ti m e t o f ertilit y tr e at m e nt 

7 
 
S af ety Ev al u ati o ns
S af ety Ev al u ati o ns  
All c o m plic ati o ns r el at e d t o b ot h st u d y ar ms will b e r ec or d e d, i ncl u di n g 
p ai n, i n a bilit y t o c o m pl et e pr oc e d ur e, bl e e di n g, i nf ecti o n, or i nj ur y t o t h e 
f e m al e r e pr o d ucti v e tr act. 
St atistic al a n d A n alytic 
St atistic al a n d A n alytic 
Pl a n
Pl a n  
2 s a m pl e t - t est will b e us e d t o c o m p ar e m e a n q u esti o n n air e sc or es a n d 
d el a y i n  tr e at m e nt c o m p aris o n will b e c o m p ar e d wit h c hi s q u ar e d t ests.  If 
si g nific a nt diff er e nc es exist i n d e m o gr a p hic f e at ur es b et w e e n gr o u ps, 
l o gistic r e gr essi o n will b e p erf or m e d t o acc o u nt f or t h es e. Dr. P at o u n a kis 
will assist wit h st atistic al a n al ysis . T his is ex pl ai n e d i n f urt h er d et ail i n 
s ecti o n 6. 
D A T A A N D 
A T A A N D S A F E T Y 
A F E T Y 
M O NI T O RI N G 
O NI T O RI N G P L A N
L A N 
T h e Pri nci p al I n v esti g at or is r es p o nsi bl e f or p ers o n all y o v ers e ei n g t h e 
tr e at m e nt of all st u d y p ati e nts. T h e Pri nci p al I n v esti g at or m ust ass ur e 
t h at all st u d y sit e p ers o n n el, i ncl u di n g s u b-i n v esti g at ors a n d ot h er st u d y 
st aff m e m b ers, a d h er e t o t h e st u d y prot oc ol a n d all F D A/ G C P/ N CI 
r e g ul ati o ns a n d g ui d eli n es r e g ar di n g cli nic al tri als b ot h d uri n g a n d aft er 
st u d y c o m pl eti o n. T h e Pri nci p al I n v esti g at or is willi n g t o pr o vi d e acc ess t o 
h er ori gi n al r ec or ds t o p er mit v erific ati o n of pr o p er e ntr y of d at a. At t h e 
co m pl eti o n of t h e st u d y, a n y a n d all m a n uscri pts will b e r e vi e w e d b y t h e 
Pri nci p al I n v esti g at or a n d will r e q uir e h er fi n al si g n at ur e t o v erif y t h e 
acc ur ac y of t h e d at a.  
T h e PI will m o nit or a n d e v al u at e t h e s af et y of t h e s u bj ects t hr o u g h o ut 
t h e c o urs e of t he r es e arc h st u d y, b y w a y of r e g ul ar ( e v er y 6 m o nt hs) 
m e eti n gs.  If a d v ers e eff ects ar e a p pr eci at e d d uri n g a n offic e 
h yst er osc o p y, t h e h yst er osc o p y will b e st o p p e d i m m e di at el y, a n y m e dic al 
c o nc er ns a d dr ess e d a p pr o pri at el y, a n d alt er n at e pl a ns m a d e f or ut eri n e 
c a vit y e v al u ati o n m a d e. 
C o nfi d e nti al i nf or m ati o n will b e pr ot ect e d b y m ai nt ai ni n g r ec or ds i n a 
s ec ur e, l oc k e d f acilit y a n d d ei d e ntifi e d  fil es.  O nl y t h os e p ers o ns dir ectl y 
i n v ol v e d wit h t h e pr ot oc ol will h a v e acc ess t o p ers o n al h e alt h 
i nf or m ati o n.  D at a will o nl y b e pr es e nt e d a n d p u blis h e d i n a g gr e g at e 
f or m wit h n o p ers o n al i d e ntifi ers. 
O ur r es e arc h gr o u p h as b e e n tr ai n e d i n h u m a n s u bj ects' pr ot ecti o n a n d 
o nl y tr ai n e d pr oj ect st aff o p er ati n g u n d er t h e I R B a p pr o v al f or t h e pr oj ect 
will h a v e acc ess t o t h e c o nfi d e nti al i n di vi d u all y i d e ntifi a bl e d at a, a n d all 
d at a will b e a g gr e g at e d or a n o n y miz e d f or p u blic ati o n.  
S T U D Y 
T U D Y T E A M
E A M  
S ar a h M o ust af a, M D, Pri nci p al I n v esti g at or ( U N C)  
Li n n e a G o o d m a n, F act ult y A d vis or ( U N C)  
G e or g e P at o u n a kis, M D, P h D, Bi ost atistici a n , ( RM A Fl ori d a)  
 
 
 
 
 
 

8 
 
1. B A C K G R O U N D A N D R A TI O N AL E  
 
1. 1  
I ntr o d ucti o n 
S ali n e i nf usi o n s o n o gr a p h y ( SI S) a n d h yst er osc o p y ar e c o m m o nl y e m pl o y e d m et h o ds f or ut eri n e c a vity 
e v al u ati o n. SI S is oft e n p erf or m e d as a scr e e ni n g t o ol i n t h e offic e f or ut eri n e e v al u ati o n si nc e it is str ai g ht-
f or w ar d t o p erf or m, w ell-t ol er at e d h as l o w ov er h e a d c ost.  If ut eri n e p at h ol o g y is s us p ect e d o n SI S, s u bs e q u e nt 
h yst er osc o p y is t y pic all y p erf or m e d i n t h e o p er ati n g r o o m. H yst er osc o p y r e m ai ns t h e g ol d st a n d ar d f or 
di a g n osis of i ntr a -ut eri n e p at h ol o g y a n d off ers t h e o p p ort u nit y f or i nt er v e nti o n at ti m e of di a g n osis, b ut oft e n is 
n ot us e d as t h e i niti al scr e e ni n g t o ol b ec a us e of pr o vi d er c o nc er ns a b o ut i n -offic e t ol er a bilit y, e q ui p m e nt c ost 
a n d m ai nt e n a nc e. T ec h n ol o g y a d v a nc e m e nts, h o w e v er, h as i ntr o d uc e d a n aff or d a bl e, dis p os a bl e, s m all c ali b er 
h yst er osc o p e s wit h a n o p er ati v e c h a n n el t o m a k e it p ossi bl e f or t his t y p e of ass ess m e nt t o b e p erf or m e d i n t h e 
offic e s etti n g  wit h t h e a d diti o n of a ‘s e e a n d tr e at’ m o d alit y . If us e d t o p erf or m i niti al ut eri n e c a vit y ev al u ati o n, 
h yst er osc o p y m a y off er ex p e dit e d di a g n osis, tr e at m e nt, a n d a v oi d a nc e of g e n er al a n est h esi a. If s u p eri or 
s p ecificit y is d e m o nstr at e d, it m a y als o l o w er t h e f als e p ositi v e r at e, pr e v e nti n g u n n ec ess ar y d el a ys t o a 
p ati e nt’s pr oj ect e d tr e at m e nt pl a n, a n d u n n ec ess ar y ex p os ur e t o a n est h esi a ris ks. T o d at e, n o r a n d o miz e d 
c o ntr ol tri als h a v e c o m p ar e d t h e s atisf acti o n of p ati e nts  a n d pr o vi d ers  wit h t h e  i nf ertilit y w or k u p ex p eri e nc e 
w h e n utilizi n g a si n gl e st e p pr oc ess f or e v al u ati o n a n d tr e at m e nt ( offic e h yst er osc o p y) , as o p p os e d t o a t w o-st e p 
pr oc ess, wit h s e p ar at e pr oc e d ur es sc h e d ul e d t o di a g n osis a n d t h e n tr e at if i n dic at e d.  T h e e v al u ati o n a n d 
m a n a g e m e nt of i nf ertilit y is oft e n a str essf ul a n d ti m e i nt e nsi v e pr oc ess, oft e n r e q uiri n g d el a ys i n t esti n g a n d 
i nt er v e nti o n t o c o or di n at e wit h m e nstr u al c ycl e ti mi n g. T h er ef or e, i n pr o m oti n g a p ati e nt -c e nt er e d ex p eri e nc e, 
it m a y b e b e n efici al t o mi ni miz e st e ps pr oc e e di n g ulti m at e tr e at m e nt g o als, s uc h as i n vitr o f ertiliz ati o n.  
T h e Li N A O p er a Sc o p e is a n F D A a p pr o v e d dis p os a bl e 4. 2 m m offic e h yst er osc o p e wit h a n o p er ati v e c h a n n el t h at 
all o ws f or a ‘s e e a n d tr e at’ offic e m o d alit y f or mi n or t o m o d er at e p at h ol o g y s uc h as p ol y ps a n d mi n or a d h esi o ns 
wit h o ut a n est h esi a. T h e d e vic e b ec a m e a v ail a bl e o n t h e m ar k et i n A u g ust 2 0 1 8, a n d its us e w as i m m e di at el y 
i m pl e m e nte d i n o ur cli nic, as w ell as acr oss t h e c o u ntr y . T h e d e vic e f u ncti o ns as st a n d ar d offic e h yst er osc o p es 
b ef or e it, wit h t h e a d diti o n of a n o p er ati v e p ort, a n d all pr o vi d ers i n t his st u d y ar e pr ofici e nt i n its us e a n d h a v e 
utiliz e d it pri or t o t h e st u d y st ar t.  
 
1. 2  
N a m e a n d D escri pti o n of I n v esti g ati o n al Pr o d uct or I nt er v e nti o n  
 As pr e vi o usl y n ot e d, t his d e vic e is n o l o n g er c o nsi d er e d i n v esti g ati o n al, a n d is pr ofici e ntl y a n d r e g ul arl y us e d i n 
o ur pr actic e a n d n ati o n all y.  
1. 3  
N o n -Cli nic al a n d Cli nic al St u d y Fi n di n gs  
 
P ot e nti al b e n efits t h e i nt er v e nti o n ar m of t his st u d y is f e w er f als e p ositi v es, gi v e n dir ect vis u aliz ati o n of t h e 
ut eri n e c a vit y, a n d t h e a bilit y t o m a n a g e p at h ol o g y at ti m e of di a g n osis. T his m a y off er si g nific a nt i m p act t o t h e 
p ati e nt b y a v oi di n g a n est h esi a a n d a pr oc e d ur e i n t h e o p er ati n g r o o m wit h ass oci at e d b ur d e ns. It is li k el y als o t o 
si g nific a ntl y s h ort e n ti m e t o pl a n n e d tr e at m e nt g o als, w hic h i n o ur p o p ul ati o n of p ati e nt is 
c o nc e pti o n/ pr e g n a nc y. 
 
 

9 
 
1. 4        R el e v a nt Lit er at ur e a n d D at a  
S ali n e i nf usi o n s o n o gr a p h y is r o uti n el y e m pl o y e d m et h o d of e v al u ati o n f or ut eri n e c a vit y a b n or m aliti es. St u di es 
h a v e s h o w n a s e nsiti vit y of 8 3 % a n d s p ecificit y of 6 0 % 1 f or t h e d et ecti o n of a n y p at h ol o g y wit h SI S.  Esc al ati o n t o 
o p er ati n g -r o o m b as e d h yst er osc o p y f or f urt h er e v al u ati o n of i ntr a -ut eri n e p at h ol o g y i n t h e c o nt ext of l o w 
s p ecificit y, l e a ds t o hi g h n u m b er of u n n ec ess ar y pr oc e d ur es u n d er g e n er al a n est h esi a. T his oft e n r es ults i n 
u n n ec ess ar y d el a ys t o tr e at m e nt, a n d u n d u e str ess a n d i nc o n v e ni e nc e t o t h e p ati e nt. 
H yst er osc o p y is r e g ar d e d as t h e g ol d st a n d ar d f or ut eri n e c a vit y e v al u ati o n wit h s e nsiti vit y of 9 7 % a n d s p ecificity 
of 9 2 % 2.  W hil e i n h er e nt ris k of h yst er osc o p y is < 1 %
3, t h e us e of g e n er al a n est h esi a r es ults i n a d diti o n al 
m or bi dit y ris ks
4, d el a ys of pri m ar y tr e at m e nt g o als, a n d t h e occ u p ati o n of m a n y a d diti o n al r es o urc es a n d 
p ers o n n el.  
Offic e h yst er osc o p y h as off er e d a disti nct o p p ort u nit y t o a v oi d t h es e a d diti o n al ris ks, a n d a str e a mli n e d 
a p pr o ac h f or p ati e nts a n d pr o vi d ers t o c o m pl et e e v al u ati o ns effici e ntl y. P ati e nt s atisf acti o n sc or es h a v e b e e n 
si mil ar b et w e e n offic e b as e d a n d o p er ati n g r o o m b as e h yst er osc o p y, w hil e r ec o v er y ti m e a n d ti m e a w a y fr o m 
w or k or h o m e is si g nific a ntl y s h ort er i n t h e f or m er 5. O p er ati v e offic e h yst er osc o p y f or p oly p ect o m y a n d l ysis 
i ntr a ut eri n e s y n ec hi a e h as pr o v e n a s af e, eff ecti v e, a n d c ost-eff ecti v e alt er n ati v e t o o p er ati n g -r o o m b as e d 
h yst er osc o p y 6 , 7, 8.   
T h e g o al of t his st u d y is t o e v al u at e if offic e h yst er osc o p y is s u p eri or t o SI S i n a r o uti n e c a vit y e v al u ati o n pri or t o 
i n-vitr o f ertiliz ati o n.  
 
2  
S T U D Y O BJ E C TI V E   
T h e o bj ecti v e of t his st u d y is t o  c o m p ar e p ati e nt a n d pr o vi d er s atisf acti o n wit h offic e h yst er osc o p y (st u d y ar m) 
v ers us s ali n e i nf usi o n s o n o gr a p h y  (c o ntr ol ar m) f or ut eri n e c a vit y e v al u ati o n, a n d t o c o m p ar e ti m e t o i nf ertility 
tr e at m e nt. 
 
T h e  h y p ot h es es ar e as f oll o ws:  
1) S atisf acti o n: P r o vi d ers will ex p eri e nc e h ei g ht e n e d s atisf acti o n sc or es o v er all wit h t h e a bilit y t o m or e 
acc ur at el y vis u aliz e t h e ut eri n e c a vit y,  p ati e nts will h a v e e q u al p ai n sc or es b et w e e n m o d aliti es a n d b ot h p ati e nts 
a n d pr o vi d ers will h a v e o v er all i ncr e as e d s atisf acti o n d u e t o a c o m pl et e ass ess m e nt a n d tr e at m e nt w h e n 
i n dic at e d, ex p e diti n g t h e ulti m at e c ar e g o als.   
2) Ti m e t o i nf ertilit y tr e at m e nt: P ati e nts i n t h e st u d y ar m will e nc o u nt er s h ort er ti m es t o d esir e d tr e at m e nt as 
t h e y will b e a bl e t o h a v e p at h ol o g y tr e at e d at ti m e of di a g n osis. 
 
3) Pr o vi d ers will b e a bl e t o c o m pl et e c a vit y ass ess m e nt a n d tr e at m e nt of e nc o u nt er e d p at h ol o g y t h e m aj ori ty of 
ti m e t h at it is e nc o u nt er e d wit h offic e h yst er osc o p y.  
 
2. 1  
Pri m ar y O bj ecti v e  
1. C o m p ar e  pr o vi d er a n d  p ati e nt s atisf acti o n b et w e e n SI S  a n d  offic e  h yst er osc o p y  
2.  R e p ort  o n  c a p a bilit y of  offic e  h yst er osc o p y  t o a d e q u at el y tr e at ut eri n e p at h ol o g y  a n d  a v oi d o p er ati n g r o o m 
m a n a g e m e nt  
3. R e p ort  o n  i nci d e nc e of  d el a y of  f ertilit y tr e at m e nt i n e ac h gr o u p  
 

1 0  
 
2. 2  
S ec o n d ar y O bj ecti v e  
Ai m 2. C h ar act eriz e a n d c o m p ar e m et h o ds SI S a n d offic e h yst er osc o p y i n t er ms of t h e pr o p orti o n of p ati e nts 
wit h eit h er i nc o m pl et e c a vit y i m a gi n g or p at h ol o g y n ot e d r e q uiri n g i nt er v e nti o n i n t h e o p er ati n g r o o m  a n d 
e v al u at e ti m e t o i niti ati o n of d esir e d f ert ilit y tr e at m e nt. 
 
3  
I N V E S TI G A TI O N AL PL A N ( bri ef o v er vi e w) 
3. 1  
St u d y D esi g n  
T y p e of d esi g n: R a n d o miz e d C o ntr ol Tri al  
3. 2  
All oc ati o n t o Tr e at m e nt Gr o u ps a n d Bli n di n g (if a p plic a bl e)  
Ut eri n e c a vit y e v al u ati o n is a r o uti n e st e p pri or t o i niti ati o n of i n -vitr o f ertiliz ati o n (I V F) tr e at m e nt. Wh e n a 
p ati e nt h as c h os e n I V F as t h eir tr e at m e nt pl a n, s h e will b e ass ess e d f or eli gi bilit y i n t h e st u d y. If s h e m e ets 
crit eri a, t h e st u d y i nf or m ati o n will b e disc uss e d,  a n d writt e n m at eri al pr o vi d e d .  T h e y will b e c o u ns el e d o n ris ks 
a n d b e n efits of e ac h ar m b ef or e c o ns e nt f or r a n d o miz ati o n a n d  will h a v e  a d e q u at e ti m e ( a p pr oxi m at el y t w o 
w e e ks) t o r e vi e w, as k q u esti o ns, or wit h dr a w pri or t o t h e pr oc e d ur e . F oll o wi n g r ecr uit m e nt a n d i nf or m e d 
c o ns e nt, s u bj ects will b e r a n d o miz e d to c o ntr ol  ( SI S) or st u d y ( offic e h yst er osc o p y).   
W h e n a p ati e nt is e nr oll e d, a n o p a q u e e n v el o p e c o nt ai ni n g “c o ntr ol  ar m ” or “st u d y arm”  will b e o p e n e d t o 
d et er mi n e w hic h ar m t h e p ati e nt will b e e nr oll e d. T h e o p a q u e e n v el o p es will n ot b e pr e p ar e d b y t h e st u d y 
m e m b ers ex ec uti n g t h e pr oc e d ur es a n d will b e pr e p ar e d i n acc or d a nc e t o a bl oc k ra n d o miz ati o n sc h e m e 
o utli n e d b y w w w. R a n d o miz ati o n.c o m , i n or d er t o acc o u nt f or c h a n g es i n s kill a n d t ec h ni q u e o v er ti m e.  O nl y 2 
pr o vi d ers, b ot h wit h ex p eri e nc e usi n g t h e  Li N a O p er asc o p e will p erf or m  t h e h yst er osc o pi es i n t h e st u d y. D u e t o 
t h e n at ur e of t h e pr oc e d ur e, bli n di n g f or s u bj ects or i n v esti g at ors w o ul d n ot b e p ossi bl e. At ti m e of st atistic al 
a n al ysis, t h e i n v esti g at or p erf or mi n g a n al ysis will b e bli n d e d fr o m t h e gr o u p fr o m w hic h d at a w as o bt ai n e d.  
3. 3  
St u d y D ur ati o n, E nr oll m e nt a n d N u m b er of S u bj ects  
E a c h s u bj ect’s p artici p ati o n will l ast f or t h e d ur ati o n of t h eir ut eri n e c a vit y e v al u ati o n , s u bs e q u e nt q u esti o n n air e 
a n d t h e y will b e f oll o w e d u ntil t h er e is r es ol uti o n of a n y p at h ol o g y e nc o u nt er e d f or fi n al o utc o m es . R ecr uit m e nt 
is ex p ect e d t o l ast f or o n e y e ar wit h t h e e ntir e st u d y ex p ect e d t o l ast t w o y e ars. W e pl a n t o e nr oll a mi ni m u m of 
6 0 s u bj ects.  
3. 4  
St u d y P o p ul ati o n  
P ati e nts will b e c o ns ec uti v el y r ecr uit e d at a si n gl e ac a d e mic I V F pr o gr a m.  
I ncl usi o n Crit eri a: S u bj ects a g ed 1 8 – 5 0  y e ars  a n d  u n d er g oi n g r o uti n e c a vit y e v al u ati o n f or i n vitr o-f ertiliz ati o n 
tr e at m e nt c ycl es. 
Excl usi o n Crit eri a: Cli nic al or r a di ol o gic s us pici o n of s e v er e p at h ol o g y i ncl u di n g m y o m as,  i ntr a ut eri n e a d h esi o ns 
or r et ai n e d pr o d ucts of c o nc e pti o n, a n d t h os e wit h m e dic al crit eri a n ot s uit a bl e offic e h yst er osc o p y  d u e t o t h e 
a ntici p at e d r e q uir e m e nt of m or e a d v a nc e d r es o urc es a v ail a bl e i n t h e h os pit al s etti n g o nl y  s uc h as hist or y of a 
bl e e di n g dis or d er or ot h er m e dic al c o - m or bi diti es. 
 
4  
S T U D Y P R O C E D U R E S    
4. 1  
Scr e e ni n g/ B as eli n e Visit pr oc e d ur es  
At ti m e of r ecr uit m e nt, t h e f oll o wi n g p ati e nt i nf or m ati o n will b e o bt ai n e d ( or r e vi e w e d, if c oll ect e d i n pri or 
visits): A g e  ( y e ars), B MI ( k g/ m2), d e m o gr a p hic v ari a bl es (r ac e, et h nicit y) , gr a vi dit y/ p arit y, P M H, a n d P S H. 

1 1  
 
4. 2  
I nt er v e nti o n/ Tr e at m e nt pr oc e d ur es  
All pr oc e d ur es will b e sc h e d ul e d i n t h e first t e n d a ys of m e nstr u al c ycl e, i n or d er t o a v oi d p ossi bilit y of 
pr e g n a nc y. If p ati e nt h as irr e g ul ar c ycl es, a uri n e pr e g n a nc y t est will b e p erf or m e d a n d c o nfir m e d n e g ati v e pri or 
t o pr oc e d ur e. 
P ati e nts r a n d o miz e d t o t h e c o ntr ol ar m will h a v e st a n d ar d c a vit y e v al u ati o n wit h SI S . T his is  p erf or m e d b y 
pl ac e m e nt of s p ec ul u m, pr e p pi n g t h e c er vix  wit h b et a di n e , pl ac e m e nt of s m all fl exi bl e c at h et er, i nstill ati o n of 
n or m al s ali n e w hil e r ec or di n g i m a g es of fl ui d -dist e n d e d c a vit y.  T h os e wit h i d e ntifi e d p at h ol o g y will u n d er g o 
t y pic al m a n a g e m e nt of o ur pr actic e w hic h i ncl u d es:  If i m a gi n g is u ncl e ar or e q ui v oc al, t h e y m a y b e off er e d 
r e p e at SIS a n d/ or if SI S cl e arl y d e picts a s us p ect e d p at h ol o g y, t h e p ati e nts will u n d er g o o p er ati v e h yst er osc o p y 
i n t h e o p er ati n g r o o m at t h e n ext a v ail a bl e d at e.  
T h os e r a n d o miz e d t o t h e i nt er v e nti o n ar m will u n d er g o h yst er osc o p y wit h o n e of t h e st u d y i n v esti g at or s, all of 
w h o m ar e f ull y tr ai n e d a n d h a v e pri v il e g es t o p erf or m h yst er osc o p y  at U N C . A s p ec ul u m will b e pl ac e d, t h e 
c er vix will b e pr e p p e d wit h b et a di n e , a n d t h e h yst er osc o p e i ntr o d uc e d.  H y dr o -dist e nsi o n will b e acc o m plis h e d 
usi n g n or m al s ali n e  usi n g gr a vit y . Pict ur es of t h e ut eri n e c a vit y will b e o bt ai n e d. If p at h ol o g y ( p ol y ps or mil d 
a d h esi o ns  ar e  vis u aliz e d, t h e ass oci at e d h yst er osc o pic gr as p ers  will b e i ntr o d uc e d t hr o u g h t h e o p er ati v e p ort 
a n d us e d t o att e m pt t h er a p e utic i nt er v e nti o n o n vis u aliz e d p at h ol o g y, b y utiliz ati o n of gr as p ers t o r e m o v e 
p ol y ps or a d h esi o ns. R es ults of t h e pr oc e d ur e will b e r ec or d e d, a n d s p eci m e ns s e nt f or p at h ol o g y e v al u ati o n as 
i n dic at e d. If eff orts t o i ntr o d uc e t h e h yst er osc o p y t hr o u g h t h e c er vix ar e u ns ucc essf ul or if w e ar e u n a bl e t o 
r e m o v e a n i d e ntifi e d i ntr a ut eri n e p at h ol o g y or p ati e nt disc o mf ort is t o o hi g h ( as d efi n e d b y t h e p ati e nt), t h e 
pr oc e d ur e will b e a b ort e d a n d t h e p ati e nt sc h e d ul e d f or i nt er v e nti o n i n t h e o p er ati n g r o o m  at U N C , as is 
st a n d ar d. N o l oc al a n al g esi a will b e us e d  ( as is st a n d ar d pr actic e i n o ur offic e), b ut p ati e nts will b e e nc o ur a g e d 
t o t a k e i b u pr of e n at h o m e as is st a n d ar d. T h e y will b e c o u ns el e d t o d o t his pri or t o SI S as w ell. 
If ut eri n e c a vit y vis u aliz ati o n is u n a bl e t o b e c o m pl et e d wit h h yst er osc o p y f or a n y r e as o n, a n SI S will b e 
p erf or m e d. P ati e nts will b e ass ess e d acc or di n g t o i nt e nti o n t o tr e at.  T h er ef or e , p ati e nts r a n d o miz e d t o 
h yst er osc o p y a n d ulti m at el y r e q uir e a n SI S will b e c o nsi d er e d a f ail ur e of h yst er osc o p y t o a p pr o pri at el y vis u aliz e 
t h e ut eri n e c a vity, a n d t h e SI S will n ot b e c o nsi d er e d i n t h e fi n al e v al u ati o n as it w as n ot t h e i nt e n d e d ar m f or 
t h at p ati e nt.  
T h e o utc o m e of t h e s u bs e q u e nt o p er ati n g r o o m o p er ati v e h yst er osc o p i es will b e r ec or d e d t o e v al u at e t h e 
p ositi v e pr e dicti v e v al u e of b ot h gr o u ps.  
W e will r ec or d fi n di n gs of b ot h i m a gi n g m o d aliti es f or e ac h p ati e nt, s o t h at s u b gr o u p a n al ysis o n p ati e nt 
s atisf acti o n b as e d o n p at h ol o g y i d e ntifi e d m a y b e p erf or m e d if i n dic at e d. 
T h e r es e arc h sit e is a f acilit y w hic h r o uti n el y p erf or ms offic e h yst er osc o p y, SI S, dil ati o n a n d c ur ett a g e, e g g 
r etri e v als, e m br y o tr a nsf ers, ut eri n e bi o psi es, a n d p el vic ultr as o u n ds. It h as a f ull y e q ui p p e d O R t o m a n a g e t h es e 
pr oc e d ur es. P ati e nts w h o ar e d e e m e d hi g h ris k m e dic all y acc or di n g t o t h e excl usi o n crit eri a will n ot b e e nr oll e d 
i n t h e st u d y, as o ur O R is n ot e q ui p p e d t o m a n a g e s eri o us a d v ers e e v e nts ( w hic h ar e n ot a ntici p at e d as a ris k i n 
t his pr oc e d ur e). All n ursi n g st aff i n o ur f acilit y h as alr e a d y b e e n tr ai n e d o n h o w t o assist wit h offic e 
h yst er osc o p y.  
 
4. 3  
F oll o w - u p pr oc e d ur es  
As is st a n d ar d f or o ur cli nic, if t h er e is c o nc er n f or p at h ol o g y i n t h e c o ntr ol ar m, t h e p ati e nt will eit h er u n d er g o  
r e p e at SI S or h yst er osc o p y i n t h e o p er ati n g r o o m, at t h e pr o vi d er’s discr eti o n. P ati e nt in t h e st u d y ar m will b e 

1 2  
 
s e nt t o t h e o p er ati n g r o o m if a n i nt er v e nti o n is r e q uir e d a n d u n a bl e t o b e c o m pl et e d at ti m e of i niti al e v al u ati o n 
( h yst er osc o p y). O nc e a p ati e nt is r o ut e d t o t h e o p er ati n g r o o m f or m a n a g e m e nt, o utc o m es will b e r e p ort e d.  
P ati e nt a n d pr o vi d er q u esti o n n air es will b e a d mi nist er e d aft er t h e c o m pl eti o n of SI S or i n -offic e h yst er osc o p y. 
Si nc e t h er e will b e n o us e of m e dic ati o n t o alt er c o nsci o us n ess, it is ex p ect e d t h at p ati e nts will b e i n a p pr o pri at e  
c o n diti o n t o c o m pl et e a q u esti o n n air e aft er t h eir pr oc e d ur e.  
4. 4  
U nsc h e d ul e d visits  
T h e PI will b e n otifi e d of a n y visits t h at occ ur as a dir ect r es ult of t h e offic e h yst er osc o p y. P ati e nts will b e 
acc o m m o d at e d as s o o n as p ossi bl e, a n d t h er e is a p h ysici a n a v a il a bl e 2 4 h o urs/ d a y f or e m er g e nci es. A n y n o n-
r o uti n e visits, c alls, or c o nc er ns t h at r es ult fr o m t h e eit h er ar m of t h e st u d y will b e r ec or d e d. 
4. 5  
C o nc o mit a nt M e dic ati o n d oc u m e nt ati o n  
N ot a p plic a bl e  
4. 6  
S u bj ect C o m pl eti o n/ Wit h dr a w al pr oc e d ur es  
A p ati e nt m a y wit h dr a w at a n y ti m e b y c o nt acti n g t h e U N C F ertilit y offic e t o i n dic at e t h eir d esir e t o d o s o.  T h e y 
will als o b e as k e d o n t h e d a y of t h e pr oc e d ur e if t h e y still wis h t o p artici p at e i n t h e st u d y pri or t o b e gi n ni n g.  It 
will b e t h e p ers o n al r es p o nsi bilit y of t h e PI t o dis p os e of a n y ass oci at e d d at a c oll ect e d t o t h at ti m e p oi nt 
a p pr o pri at el y.  
4. 7  
Scr e e n f ail ur e pr oc e d ur es  
P ati e nts w h o d o n ot q u alif y f or t h e st u d y will u n d er g o st a n d ar d e v al u ati o n a n d tr e at m e nt b y o ur cli nic.  
 
5  
S T U D Y E V AL U A TI O N S A N D M E A S U R E M E N T S  
At ti m e of r ecr uit m e nt, t h e f oll o wi n g p ati e nt i nf or m ati o n will b e o bt ai n e d ( or r e vi e w e d, if c oll ect e d i n pri or 
visits): A g e, B MI, d e m o gr a p hic v ari a bl es, i n dic ati o n f or c a vit y e v al u ati o n, gr a vi dit y/ p arit y, P M H, a n d P S H. 
P ati e nts i n i nt er v e nti o n ar m w o ul d n ot b e s u bj ect e d t o a d diti o n al ex a ms or m e dic al i n v esti g ati o n t h a n t h os e i n 
t h e c o ntr ol ar m. 
S atisf acti o n sc or es will b e c alc ul at e d fr o m  a st a n d ar diz e d q u esti o n n air e utilizi n g a r ati n g sc al e  fr o m 6-3 0 (s e e 
a p p e n dix)  f or p a ti e nts a n d pr o vi d ers. 
5. 1 Effic ac y E v al u ati o n  
Effic ac y will b e c alc ul at e d b as e d o n a bilit y t o o bt ai n s atisf act or y ut eri n e c a vit y i m a gi n g b y pr o vi d ers , as d efi n e d 
b y t h e pr o vi d er,  a n d s atisf acti o n of pr oc e d ur e ex p eri e nc e b y t h e p ati e nt. M e a n s atisf acti o n sc or es will b e 
c alc ul at e d a n d c o m p ar e d. 
F or t h e s ec o n d ar y e n d p oi nt, effic ac y will b e c alc ul at e d b as e d o n pr o p orti o n of p ati e nts wit h eit h er i nc o m pl et e 
c a vit y i m a gi n g or p at h ol o g y not e d r e q uiri n g i nt er v e nti o n i n t h e o p er ati n g r o o m .  Ti m e t o tr e at m e nt will b e 
c o m p ar e d wit h t h os e wit h n or m al fi n di n gs o n eit h er m et h o d ut eri n e e v al u ati o n a n d t h os e wit h p at h ol o g y 
s ucc essf ull y r e m o v e d i n t h e st u d y ar m at ti m e of di a g n osis d efi n e d as 0 ( or i m m e di at e), t h os e wit h fi n di n gs 
r e q uiri n g o p er ati v e i nt er v e nti o n usi n g d a ys t o sc h e d ul e d O R visit as a c o nti n u o us v ari a bl e.  
T h e n u m b er of p ati e nts wit h p at h ol o g y r e q uiri n g i nt er v e nti o n n ot e d will b e r ec or d e d f or e ac h gr o u p. If t his is 
si g nific a ntl y diff er e nt b et w e e n gr o u ps, l o gistic r e gr essi o n will b e p erf or m e d t o c o ntr ol f or t his diff er e nc e. 

1 3  
 
5 . 2 S af et y E v al u ati o ns 
P ot e nti al ris ks of offic e h yst er osc o p y i ncl u d e bl e e di n g, i nf ecti o n, p ai n,  ut eri n e p erf or ati o n,  or i n a bility t o 
c o m pl et e t h e pr oc e d ur e. Si g nific a nt bl e e di n g or i nf ecti o n is exc e e di n gl y r ar e wit h h yst er osc o p y.  If si g nific a nt 
disc o mf ort is e nc o u nt er e d, t h e pr oc e d ur e will b e a b ort e d.  I n o ur pr actic e, t his occ urs at si mil ar r at es b et w e e n 
t h es e t w o pr oc e d ur es, w hic h is l ess t h a n 5 % of pr oc e d ur es. 
  
All pr oc e d ur es will b e p erf or m e d wit h st a n d ar d m et h o ds, a n d a n y c o m plic ati o ns or a d v ers e eff ects or c o nc er ns 
will b e r ec or d e d a n d r e p ort e d.  T h e ris k ass oci at e d wit h h yst er osc o p y is < 1 % 3. A d v ers e e v e nts will b e r ec or d e d b y 
st u d y m e m b ers as t h e y ar e r e p ort e d b y p artici p a nts. All a d v ers e e v e nts occ urri n g d uri n g t h e st u d y will b e 
d oc u m e nt e d , a n d r e p ort e d t o t h e f ac ult y a d vis or, w h o will b e a v ail a bl e eit h er o n-sit e or vi a c ell p h o n e t o disc uss 
a n y s af et y iss u es t h at aris e. T h e occ urr e nc e of a d v ers e e v e nts will b e ass ess e d d uri n g t h e st u d y a n d t h e f ac ulty 
a d vis or will f oll o w all a d v ers e e v e nts t o t h e p oi nt of s atisf act or y r es ol uti o n. I m m e di at e a n d a p pr o pri at e m e dic al 
c ar e will b e pr o vi d e d as i n dic at e d, a n d st u d y p ers o n n el ar e ex p eri e nc e d a n d q u alifi e d i n m a n a gi n g c o m plic ati o ns 
of ut eri n e i m a gi n g pr oc e d ur es . 
T h e r at e of a d v ers e e v e nts b et w e e n e ac h gr o u p will als o b e r ec or d e d.  
 
6  
S T A TI S TI C AL C O N SI D E R A TI O N    
6. 1  
Pri m ar y E n d p oi nt  
S atisf acti o n sc or es of p ati e nts a n d pr o vi d ers  
6. 2  
S ec o n d ar y E n d p oi nt  
Ti m e t o i nf ertilit y tr e at m e nt , a bilit y t o s ucc essf ull y m a n a g e i ntr a ut eri n e p at h ol o g y at ti m e of di a g n osis i n st u d y 
ar m, p ositi v e pr e dicti v e v al u e of SI S i n c o ntr ol ar m  
6. 3  
St atistic al M et h o ds  
Dr. G e or g e P at o u n a kis, wit h w h o m t h e f ac ult y a d vis or h as w or k e d ext e nsi v el y f or bi ost atistic al a n al ysis a n d will 
b e a d d e d as a f ull i n v esti g at or i n or d er t o assist a n d o v ers e e st atistic al a n al ysis.  H e h as h a d a n o p p ort u nity t o 
r e vi e w t h e pr ot oc ol a n d will c o nti n u e t o off er g ui d a nc e a n d ex p ertis e t hr o u g h o ut t h e st u d y.  
P ati e nt d e m o gr a p hics v ari a bl es , as pr e vi o usl y d efi n e d, will b e r ec or d e d a n d c o m p ar e d b et w e e n gr o u ps usi n g t -
t est f or c o nti n u o us p ar a m etric v ari a bl es ( m e a n a g e, B MI) a n d c hi s q u ar e d  (r ac e, p arit y ). If diff er e nc es ar e f o u n d, 
r e gr essi o n m o d els will b e us e d t o acc o u nt f or t h os e diff er e nc es .  
S atisf acti o n sc or es will b e  c alc ul at e d b as e d o n a bilit y t o o bt ai n s atisf act or y ut eri n e c a vit y i m a gi n g b y pr o vi d ers 
a n d s atisf acti o n of pr oc e d ur e ex p eri e nc e b y p ati e nt, as d efi n e d b y t h e r ati n g sc al e i n t h e q u esti o n n air es. T h e 
c o m bi n ati o n of m ulti pl e Li k ert sc al e r es p o ns es fr o m a si n gl e s u bj ect’s s ur v e y r es p o ns e will b e us e d as t h e 
s atisf acti o n sc or e.  C o m bi ni n g t h e m ulti pl e or di n al v ari a bl es fr o m a si n gl e s ur v e y t o o bt ai n t h e sc or e f or t h at 
p artici p a nt’s r es p o ns e i ncr e as es t h e li k eli h o o d of t h e s atisf acti o n sc or e b e h a vi n g li k e a n or m all y distri b ut e d 
v ari a bl e s o p ar a m etric st atistic al t ests c a n b e us e d.  Pri or t o a p pl yi n g t h e p ar a m etric st atistic al t ests t o t h e 
s atisf acti o n sc or es, t h e distri b uti o n of t h e sc or es will b e ass ess e d f or n or m alit y.  If t h e d at a is a p pr oxi m at el y 
n or m all y distri b ut e d, t h e n m e a n sc or es will b e c alc ul at e d i n e ac h gr o u p , a n d t-t est us e d t o c o m p ar e t h es e 
v al u es.  
Si nc e t his st u d y h as t w o pri m ar y e n d p oi nts, p ati e nt s atisf acti o n sc or e a n d pr o vi d er s atisf acti o n sc or e, 
m ulti plicit y will b e a d dr ess e d.  T o c o ntr ol f or t h e i nfl at e d T y p e I err or i n t his st u d y, t h e B o nf err o ni c orr ecti o n will 

1 4  
 
b e a p pli e d t o t h e st atistic al t est t hr es h ol ds t o ass ur e a n o v er all T y p e I err or r at e f or t h e pri m ar y o utc o m es is l ess 
t h a n 0. 0 5.   
F or t h e s ec o n d ar y e n d p oi nt, ti m e t o i niti ati o n of f ertilit y tr e at m e nt will b e e v al u at e d as i m m e di at e ( 0) if: n o 
p at h ol o g y is e nc o u nt er e d i n eit h er gr o u p or p at h ol o g y is e nc o u nt er e d a n d s ucc essf ull y tr e at e d i n t h e 
h yst er osc o p y gr o u p. Ti m e t o i niti ati o n of tr e at m e nt will b e ass ess e d as  d el a y e d b y w a y of a c o nti n u o us v ari a bl e 
of d a ys t o sc h e d ul e d r e p e at SI S or o p er ati n g r o o m s ur g er y,  if eit h er m et h o d is i nc o ncl usi v e or p at h ol o g y is 
e nc o u nt er e d i n eit h er gr o u p t h at n ec essit at es a d diti o n al o p er ati n g r o o m m a n a g e m e nt .  T h e ti m e t o c o nc ei v e 
w ill t h e n b e c o m p ar e d usi n g m e di a ns wit h i nt er q u artil e r a n g es a n d a M a n n W hit n e y - U t est f or t h e n o n-
p ar a m etric  c o nti n u o us v ari a bl e of ti m e a n d usi n g c hi -s q u ar e d t o ass es t h e bi v ari at e q u esti o ns of i m m e di at e vs. 
d el a y e d.   
T h er e s h o ul d b e mi ni m al  missi n g v ar i a bl es or dr o p o ut o nc e t h e p ati e nts h a v e st art e d c a vit y e v al u ati o n f or t h e 
pri m ar y o utc o m e of p ati e nt a n d pr o vi d er s atisf acti o n u nl ess t h er e ar e ar e as l eft bl a n k o n t h e s ur v e ys.  If ar e as 
ar e l eft bl a n k, t h e p ati e nts will b e as k e d b y a n i n v esti g at or if t hi s w as i n err or or if t h e y c h os e n ot t o a ns w er. If 
t h e y c h os e n ot t o a ns w er, t his will b e n ot e d. If p ati e nts f ail t o f oll o w-u p f or s u bs e q u e nt o p er ati v e m a n a g e m e nt 
of p at h ol o g y, ti m e t o tr e at m e nt will b e c alc ul at e d as t o t h e n e ar est a v ail a bl e O R d at e t h at t h e y w o ul d h a v e b e e n 
a bl e t o sc h e d ul e.  
T h e i nci d e nc e of p at h ol o g y b et w e e n t h e t w o gr o u ps will b e c alc ul at e d a n d if t his is si g nific a ntl y diff er e nt, 
r e gr essi o n m o d els will b e a p pli e d t o c o m p ar e ti m e t o i nt er v e nti o n  w hil e acc o u nti n g f or t his.   As all p ati e nts  will 
b e r ecr uit e d fr o m t h e s a m e p o ol of t h os e i niti ati n g I V F tr e at m e nt, w e h o p e t o mi ni miz e s el ecti o n bi as.  R es ults 
will b e pr es e nt e d as a dj ust e d m e a n diff er e nc es or a dj ust e d o d ds r ati os as dict at e d b y r e gr essi o n a n d d e p e n d e nt 
v ari a bl e  Dr. P at o u n a kis , wit h si g nific a nt ex p eri e nc e i n bi ost atistics, will assist a n d o v ers e e st atistic al a n al ysis. All 
h y p ot h esis t ests t h at ar e o bs er v e d t o b e n ot st atistic all y si g nific a nt will b e r e p ort e d as b ei n g i nc o ncl usi v e . 
 T h e f oll o wi n g est a blis h e d b est pr actic es will b e f oll o w e d:  w w w.c o ns ort -st at e m e nt. or g a n d w w w.ic mj e. or g. 
  
6. 4  
S a m pl e Siz e a n d P o w er  
Acc ur at e c alc ul ati o n of s a m pl e siz e is li mit e d b y l ac k of pri or d at a f or t h e st a n d ar d d e vi ati o n of s atisf acti o n sc or e 
r es p o ns es.  T h er ef or e, f or t his st u d y, a n ass u m pti o n will be m a d e t h at t h e “ eff ect siz e” is l ar g e a n d e q u al t o 0. 8.  
S a m pl e siz e c alc ul ati o n f or a p o w er of 8 0 %  a n d al p h a of 0. 0 5  wit h l ar g e eff ect siz e of 0. 8  f or c o m p ari n g m e a ns 
wit h a t -t est i n dic at es t h at a p pr oxi m at el y 2 5 s u bj ects ar e n e e d e d i n e ac h gr o u p . W e pl a n t o e nr oll 6 0 p ati e nts , 
3 0 i n e ac h gr o u p,  t o all o w f or a p pr oxi m at el y 2 0 %  p ati e nt dr o p o ut . 
7  
S T U D Y I N T E R V E N TI O N  
Offic e h yst er osc o p y will b e p erf or m e d i n pl ac e of SI S f or ut eri n e c a vit y e v al u ati o n. D e vic es will b e r ec ei v e d 
dir ectl y fr o m t h e m a n uf act ur er. D e vic es ar e i n s elf -c o nt ai n e d p ac k a gi n g, will b e dis p os e d of aft er o n e us e wit h 
o n e p ati e nt.  
8  
S T U D Y I N T E R V E N TI O N A D MI NI S T R A TI O N  
A d mi nistr ati o n of r a n d o miz ati o n a n d i nt er v e nti o n w h e n a p plic a bl e will b e p erf or m e d o nl y b y c o -i n v esti g at ors of 
t his st u d y. O p a q u e e n v el o p es c o nt ai ni n g t h e tr e at m e nt ar m t o w hic h e ac h s u bj ect will b e r a n d o miz e d will b e 
s e al e d a n d o p e n e d o nl y at ti m e of sc h e d uli n g offic e pr oc e d ur e.  T h e i nt er v e nti o n will b e p erf or m e d o nl y b y st u d y 
m e m b ers pr e vi o usl y tr ai n e d wit h t h e d e vi c e. 
 

1 5  
 
9  
S A F E T Y M A N A G E M E N T  
T h e Pri nci p al I n v esti g at or is r es p o nsi bl e f or p ers o n all y o v ers e ei n g t h e tr e at m e nt of all st u d y p ati e nts. A n urs e or 
m e dic al assist a nt will b e pr es e nt i n all pr oc e d ur es, as is st a n d ar d f or o ur pr actic e, t o m o nit or p ati e nt s af et y a n d 
co mf ort.  T h e Pri nci p al I n v esti g at or m ust ass ur e t h at all st u d y sit e p ers o n n el, i ncl u di n g s u b -i n v esti g at ors a n d 
ot h er st u d y st aff m e m b ers, a d h er e t o t h e st u d y pr ot oc ol a n d all F D A/ G C P/ N CI r e g ul ati o ns a n d g ui d eli n es 
r e g ar di n g cli nic al tri als b ot h d uri n g a n d aft er st ud y c o m pl eti o n. T h e Pri nci p al I n v esti g at or is willi n g t o pr o vi d e 
acc ess t o h er ori gi n al r ec or ds t o p er mit v erific ati o n of pr o p er e ntr y of d at a. At t h e c o m pl eti o n of t h e st u d y, a n y 
a n d all m a n uscri pts will b e r e vi e w e d b y t h e Pri nci p al I n v esti g at or a n d will r e q uir e h er fi n al si g n at ur e t o v erif y t h e 
acc ur ac y of t h e d at a.  
 
A d v ers e Ev e nts:  All a d v ers e e v e nts occ urri n g d uri n g t h e st u d y will b e d oc u m e nt e d  (f or u p t o 3 0 d a ys f oll o wi n g 
t h e pr oc e d ur e), a n d r e p ort e d t o t h e f ac ult y a d vis or, w h o will b e a v ail a bl e eit h er o n -sit e or vi a c ell p h o n e t o 
disc uss a n y s af et y iss u es t h at aris e. T h e occ urr e nc e of a d v ers e e v e nts  will b e ass ess e d d uri n g t h e st u d y a n d t h e 
f ac ult y a d vis or will f oll o w all a d v er se e v e nts  t o t h e p oi nt of s atisf act or y r es ol uti o n. I m m e di at e a n d a p pr o pri at e  
m e dic al c ar e will b e pr o vi d e d as i n dic at e d, a n d st u d y p ers o n n el ar e ex p eri e nc e d a n d q u alifi e d i n m a n a gi n g 
c o m plic ati o ns of ut eri n e i m a gi n g pr oc e d ur es.  Dr. M o ust af a  a n d Dr. G o o d m a n  will r e vi e w a n y r e p ort e d a d v ers e 
e v e nts wit h t h e st u d y t e a m e v er y 6 m o nt hs .  
 
1 0 . 1         M o nit ori n g Pl a n 
A d v ers e e v e nts t h at ar e p ossi bl e i ncl u d e bl e e di n g, i nf ecti o n, or i nj ur y t o t h e f e m al e r e pr o d ucti v e tr act. 
H yst er osc o p y is c o nsi d er e d a l o w -ris k offic e pr oc e d ur e, a n d n o n e of t h es e e v e nts ar e a ntici p at e d. H o w ev er, all 
p ati e n ts will b e ass ess e d f or d e v el o p m e nt of a d v ers e eff ects d uri n g t h eir visit a n d will h a v e acc ess t o a tr ai n e d 
R e pr o d ucti v e E n d ocri n ol o gist a n d I nf ertilit y S p eci alist aft er t h eir visit, w h o is o n c all 2 4 h o urs a d a y.  
 
S eri o us A d v ers e Ev e nts  
N o s eri o us a d v ers e e v e nts ar e ex p ect e d wit h t h e pr o p os e d i nt er v e nti o n . If t h e y s h o ul d occ ur, t h e y will b e 
i m m e di at el y r e p ort e d.  
 
Pr oc ess of R e p orti n g of A d v ers e Ev e nts:  
T h e tri al p eri o d is d efi n e d fr o m t h e ti m e t h at t h e i nf or m e d c o ns e nt d oc u m e nt is si g n e d u ntil t hirt y d a ys aft er t h e 
h yst er osc o p y. All s eri o us a d v ers e e v e nts occ urri n g d uri n g t his p eri o d (i ncl u di n g d e at h d u e t o a n y c a us e) m ust b e 
c o m m u nic at e d wit hi n 1 d a y of t h e i n v esti g at or b ec o mi n g a w ar e of t h e e v e nt t o d esi g n at e d p ers o n n el. A n y f at al 
or lif e -t hr e at e ni n g a d v ers e e v e nts  m ust b e r e p ort e d i m m e di at el y, b ut n o l o n g er t h a n 1 d a y fr o m t h e ti m e t h e 
i n v esti g at or b ec o m es a w ar e of t h e e v e nt. A c a us alit y ass ess m e nt will b e pr o vi d e d f or all s eri o us a d v ers e ev e nt s. 
Critic al f oll o w -u p i nf or m ati o n o n s eri o us a d v ers e e v e nts  will b e pr o vi d e d as s o o n as it is a v ail a bl e, b ut n o l o n g er 
t h a n 1 d a y fr o m t h e ti m e t h e i n v esti g at or b ec a m e a w ar e of t h e i nf or m ati o n.   
 
R e p orti n g of S er i o us A d v ers e Ev e nts 
A d v ers e e v e nts ( n o n -s eri o us) will b e r e p ort e d t o t h e PI. T h e r e p ort will c o nt ai n t h e d et ails of t h e a d v ers e e v e nt 
i ncl u di n g t e m p or alit y of e v e nt wit h st u d y tr e at m e nt, pr es e nt ati o n, a n d f oll o w-u p pl a n. T h e cli nici a n’s r ati n g of 
t h e s e v erit y of e v e nt/ eff ect is r ec or d e d f or e ac h e v e nt. T h e r ati n g will b e b as e d o n t h e cli nici a n’s j u d g m e nt of 
gr e at est s e v erit y of t h e a d v ers e e v e nts. All s eri o us e v e nts  will b e r e p ort e d wit hi n 2 4 h o urs t o t h e I R B.  
 
1 0 . 2        A d h er e nc e t o t h e Pr ot oc ol 
Exc e pt f or a n e m er g e nc y i n w hic h pr o p er c ar e f or t h e pr ot ecti o n, s af et y, a n d w ell-b ei n g of t h e st u d y p ati e nt 
r e q uir es alt er n ati v e tr e at m e nt, t h e st u d y s h all b e c o n d uct e d ex actl y as d escri b e d i n t h e a p pr o v e d pr ot oc ol.  
 

1 6  
 
1 0 . 3       A m e n d m e nts t o t h e Pr ot oc ol 
S h o ul d  a m e n d m e nts t o t h e pr ot oc ol b e r e q uir e d, t h e a m e n d m e nts will b e ori gi n at e d a n d d oc u m e nt e d b y t h e 
Pri nci p al I n v esti g at or. It s h o ul d als o b e n ot e d t h at w h e n a n a m e n d m e nt t o t h e pr ot oc ol s u bst a nti all y alt ers t h e 
st u d y d esi g n or t h e p ot e nti al ris k t o t h e p ati e nt, a r e vis e d c o ns e nt f or m mi g ht b e r e q uir e d.  
T h e writt e n a m e n d m e nt, a n d if r e q uir e d t h e a m e n d e d c o ns e nt f or m, m ust b e s e nt t o t h e I R B f or a p pr o v al pri or 
t o i m pl e m e nt ati o n. 
 
1 0 . 4        R ec or d R et e nti o n 
St u d y d oc u m e nt ati o n i ncl u d es all S p o ns or -I n v esti g at or c orr es p o n d e nc e, m o nit ori n g l o gs/l ett ers, a n d r e g ul at or y 
d oc u m e nts ( e. g., pr ot oc ol a n d a m e n d m e nts, I R B c orr es p o n d e nc e a n d a p pr o v al, si g n e d p ati e nt c o ns e nt f or ms). 
St u d y d oc u m e nts will b e k e pt o n fil e u ntil t hr e e y e ars aft er t h e c o m pl eti o n a n d fi n al st u d y r e p ort of t his 
i n v esti g ati o n al st u d y. 
 
1 0 . 5        D at a S af et y M o nit ori n g Pl a n 
T h e f ac ult y a d vis or a n d PI will m o nit or a n d e v al u at e t h e s af et y of t h e s u bj ects t hr o u g h o ut t h e c o urs e of t h e 
r es e arc h st u d y, b y w a y of r e g ul ar ( e v er y 6 m o nt hs) m e eti n gs wit h all st u d y p ers o n n el i n w hic h t h e y will r e vi e w 
t h e f oll o wi n g pr oc ess es: 
-Ass ess t h e p erf or m a nc e of t h e tri al wit h r es p ect t o s u bj ect r ecr uit m e nt, a n d d at a q u alit y a n d c o m pl et e n ess, t o 
h el p e ns ur e t h e li k eli h o o d of s ucc essf ul a n d ti m el y  tri al c o m pl eti o n.  
-R e vi e w a n d c o nsi d er a n y pr ot oc ol m o dific ati o ns or a ncill ar y st u di es pr o p os e d b y t h e st u d y i n v esti g at ors t o 
e ns ur e t h at t h es e d o n ot n e g ati v el y i m p act t h e tri al.  
-A d vis e t h e I nstit uti o n al R e vi e w B o ar d as t o w h et h er t h e pr ot oc ol s h o ul d c o nti n u e as sc h e d ul e d or u n d er g o a 
m o dific ati o n d u e t o a fi n di n g fr o m t h e m o nit ori n g pr oc ess.  
 
T h e PI will m e et wit h st u d y p ers o n n el at l e ast t wic e p er y e ar t o m o nit or t h e c u m ul ati v e s af et y d at a d uri n g t h e 
p eri o d w h e n p artici p a nts ar e i n t h e st u d y.  
 
1 0  
D A T A C OLL E C TI O N A N D M A N A G M E N T  
 
M ai nt e n a nc e of C o nfi d e nti alit y  
C o nfi d e nti al i nf or m ati o n will b e pr ot ect e d b y m ai nt ai ni n g r ec or ds usi n g R e d C a p.  O nl y t h os e p ers o ns dir ectl y 
i n v ol v e d wit h t h e pr ot oc ol will h a v e acc ess t o P HI.  D at a will o nl y b e pr es e nt e d a n d p u blis h e d i n a g gr e g at e f or m 
wit h n o p ers o n al i d e ntifi ers.  
 
O ur r es e arc h gr o u p h as b e e n tr ai n e d i n h u m a n s u bj ects ' pr ot ecti o n a n d o nl y tr ai n e d pr oj ect st aff o p er ati n g 
u n d er t h e I R B a p pr o v al f or t h e pr oj ect will h a v e acc ess t o t h e c o nfi d e nti al i n di vi d u all y i d e ntifi a bl e d at a, a n d all 
d at a will b e a g gr e g at e d or a n o n y miz e d f or p u blic ati o n.  
 
T h e el ectr o nic d at a fil e li n ki n g p ati e nt M R Ns t o t h e p ati e nt -s p ecific St u d y I D c o d es a n d gr o u p assi g n m e nt will b e 
p ass w or d -pr ot ect e d fil e o n t h e s ec ur e m e dic al sc h o ol -m a n a g e d s er v er wit h p o w er s ur g e pr ot ecti o n a n d vir us 
a n d m al w ar e i ntr u d er pr ot ecti o n a n d acc essi bl e o nl y t o t h e PI a n d f ac ult y a d vis or.  
 
D e d ucti v e discl os ur e is pr ot ect e d a g ai nst b y l ac k of us e of p a p er pri nt o uts, a gr e e m e nt t o us e d at a s ol el y f or  
st atistic al r e p ortin g a n d a n al ysis, p ass w or d pr ot ecti o n of all h e alt h d at a, a n d t h e o nl y c o p y of t h e p ati e nt M R Ns 
will b e i n a s ec ur e a n d l oc k e d d oc u m e nt as a b o v e.  
 

1 7  
 
D at a i nt e grit y will b e ass ur e d  t hr o u g h pr o m pt a n d c o m pr e h e nsi v e d oc u m e nt ati o n of t h e pr oc e d ur e, 
c o m plic ati o ns, a n d o utc o m es, i n o ur el ectr o nic m e dic al r ec or d s yst e m, Art W or ks. T his d oc u m e nt ati o n will b e 
c o m pl et e d b y t h e p h ysici a n ex ec uti n g t h e pr oc e d ur e. A n y missi n g d at a q u eri es will b e c o n d uct e d b y t h e PI, w h o 
will als o b e r es p o nsi bl e  f or a n al yzi n g d at a a n d cr e ati n g t h e d at a dicti o n ar y. 
 
A n y st u d y r el at e d d at a fil es a n d will b e m a n a g e d, pr oc ess e d, a n d st or e d i n a s ec ur e e n vir o n m e nt ( R E D C a p) .   Dr. 
S ar a h M o ust af a will b e r es p o nsi bl e f or pr o gr a m mi n g/c o m p uti n g f or d at a m a n a g e m e nt.  
 
1 1  
R E C R UI T M E N T S T R A T E G Y  
 
 Eli gi bl e s u bj ects sc h e d ul e d t o u n d er g o r o uti n e c a vit y e v al u ati o n pri or t o I V F tr e at m e nt  will b e i d e ntifi e d fr o m 
t h e U N C F ertilit y sc h e d ul e a n d r ecr uit e d o nl y b y i d e ntifi e d i n v esti g at ors. T h e i n v esti g at or will i nf or m t h e p ati e nt 
a b o ut t h e s t u d y a n d will i n vit e h er t o p artici p at e. If i nt er est e d, t h e r ati o n al e of t h e st u d y a n d its m et h o ds will b e 
d escri b e d i n d et ail  a n d t h e p ati e nt c o ns e nt e d.  
1 2  
C O N S E N T P R O C E S S  
 T h e i n v esti g at or will i d e ntif y eli gi bl e s u bj ects a n d a p pr o ac h t h e m eit h er at t h e ti m e of t h eir sc h e d ul e d 
a p p oi nt m e nt  t o disc uss I V F, or at t h e ti m e t h at ut eri n e c a vit y e v al u ati o n is sc h e d ul e d. T his will t a k e pl ac e o n sit e 
at U N C f ertilit y. All s u bj ects will h a v e t h e f ull st u d y ex pl ai n e d t o t h e m b y t h e i n v esti g at or a n d will h a v e a m pl e 
o p p ort u niti es t o as k q u esti o ns pri or t o si g ni n g c o ns e nt f or ms. C o ns e nt f or ms will b e pr o vi d e d or e m ail e d t o 
p ati e nts pri or t o si g ni n g as n e e d e d t o all o w t h e m l o n g er ti m e t o r e vi e w. I nf or m e d c o ns e nt will b e o bt ai n e d fr o m 
all p ati e nts pri or t o t h e p erf or m a nc e  of a n y st u d y -r el at e d pr oc e d ur e or i nt er v e nti o n. A c o p y of t h e si g n e d 
c o ns e nt f or m will b e gi v e n t o t h e s u bj ect a n d t h e ori gi n al will b e r et ai n e d b y r es e arc h st aff.  
 
1 3  
PL A N S F O R P U BLI C A TI O N  
T h e pl a n f or t his st u d y i ncl u d es pr es e nt ati o n i n a bstr act f or m at a n ati o n al m e eti n g a n d s u bs e q u e nt p u blic ati o n 
i n a j o ur n al i n t h e fi el d of R e pr o d ucti v e E n d ocri n ol o g y a n d I nf ertilit y.  
1 4  
R E F E R E N C E S  
1.  Si n g h V, Mis hr a B, Si n h a S, A gr a w al S, T h a k ur P. R ol e of s ali n e i nf usi o n s o n o h yst er o gr a p h y i n i nf ertility 
e v al u ati o n. J o ur n al of H u m a n R e pr o d uctiv e Sci e nc es. 2 0 1 8; 1 1( 3): 2 3 6. d oi: 1 0. 4 1 0 3/j hrs.j hrs _ 4 7 _ 1 8. 
2.  Gri m bizis G F, Ts ol a ki dis D, Mi k os T, et al. A pr os p ecti v e c o m p aris o n of tr a ns v a gi n al ultr as o u n d, s ali n e i nf usi o n 
s o n o h yst er o gr a p h y, a n d di a g n ostic h yst er osc o p y i n t h e e v al u ati o n of e n d o m etri al p at h ol o g y. F ertility a n d 
St erility . 2 0 1 0; 9 4( 7): 2 7 2 0-2 7 2 5. d oi: 1 0. 1 0 1 6/j.f ert nst ert. 2 0 1 0. 0 3. 0 4 7.  
3.  J a ns e n F. C o m plic ati o ns of h yst er osc o p y: a pr os p ecti v e, m ultic e nt er st u d y. O bst etrics & Gy n ec ol o gy . 
2 0 0 0; 9 6( 2): 2 6 6 -2 7 0. d oi: 1 0. 1 0 1 6/s 0 0 2 9 -7 8 4 4( 0 0) 0 0 8 6 5 -6.  
4.  R o d g ers A. R e d ucti o n of p ost o p er ati v e m ort alit y a n d m or bi dit y wit h e pi d ur al or s pi n al a n a est h esi a: r e s ults fr o m 
o v er vi e w of r a n d o mis e d. B mj . 2 0 0 0; 3 2 1( 7 2 7 5): 1 4 9 3-1 4 9 3. d oi: 1 0. 1 1 3 6/ b mj. 3 2 1. 7 2 7 5. 1 4 9 3.  
5.  Kr e m er C. P ati e nt s atisf acti o n wit h o ut p ati e nt h yst er osc o p y v ers us d a y c as e h yst er osc o p y: r a n d o mis e d 
c o ntr oll e d tri al. B mj . 2 0 0 0; 3 2 0( 7 2 3 0): 2 7 9-2 8 2. d oi: 1 0. 1 1 3 6/ b mj. 3 2 0. 7 2 3 0. 2 7 9.  
6.  C o o p er N A M, Cl ar k TJ, Mi d dl et o n L, et al. O ut p ati e nt v ers us i n p ati e nt ut eri n e p ol y p tr e at m e nt f or a b n or m al 
ut eri n e bl e e di n g: r a n d o mis e d c o ntr oll e d n o n -i nf eri orit y st u d y. B mj . 2 0 1 5; 3 5 0( m ar 2 3 6). d oi: 1 0. 1 1 3 6/ b mj. h 1 3 9 8. 
7.  Di w a k ar L, R o b erts T, C o o p er N, et al. A n ec o n o mic e v al u ati o n of o ut p ati e nt v ers us i n p ati e nt p ol y p tr e at m e nt f or 
a b n or m al ut eri n e bl e e di n g. BJ O G: A n I nt er n ati o n al J o ur n al of O bst etrics & Gy n a ec ol o gy . 2 0 1 5; 1 2 3( 4): 6 2 5-6 3 1. 
d oi: 1 0. 1 1 1 1/ 1 4 7 1 -0 5 2 8. 1 3 4 3 4.  
8.  B o u gi e  O, L orti e K, C h e n I, S h e n ass a H, Si n g h S. Tr e at m e nt of As h er m a n’s S y n dr o m e i n a n O ut p ati e nt 
H yst er osc o p y S etti n g. J o ur n al of Mi ni m ally I nv asiv e Gy n ec ol o gy. 2 0 1 5; 2 2( 6). d oi: 1 0. 1 0 1 6/j.j mi g. 2 0 1 5. 0 8. 3 5 6. 

1 8  
 
1 5      A P P E N DI X  
 
Q u esti o n n a ir es t o b e us e d i n t h e f ollo wi n g 2 p a g es  
 
 
 
P A TI E N T                                                                                                                                                      S u bj ect #: _ _ _ _ _ _ _ _  
D at e:  
 
  
 V er y 
u ns atisfi e d  ( 1) 
S o m e w h at 
u ns atisfi e d  ( 2) 
N e utr al  ( 3) 
S o m e w h at  s atisfi e d 
( 4) 
V ery s atisfi e d  ( 5) 
Y o ur o v er all 
pr oc e d ur e  ex p eri e nc e   
  
  
  
  
  
 
E as e of sc h e d uli n g  
 
 
 
 
 
 
P ai n c o ntr ol d uri n g t h e 
pr oc e d ur e   
  
  
  
  
  
T h e ti m e it t o ok t o 
c o m pl et e y o ur 
pr oc e d ur e   
 
 
 
 
 
U n d erst a n di n g of t h e 
r es ults of t h e 
pr oc e d ur e  
 
 
 
 
 
S atisf acti o n wit h 
f oll o w-u p pl a n of t h e 
pr oc e d ur e  
  
  
  
  
  
 
 
P ai n r ati n g o n a sc al e of 1 -1 0 ( 1 b ei n g n o n e, 1 0 b ei n g t h e w orst p ai n y o u’ v e ev er ex p eri e nc e d): _ _ _ _ _  
 
H o w li k el y ar e y o u t o r ec o m m e n d t his pr oc e d ur e t o a fri e n d ( 1 n ot at all, 1 0 extr e m el y li k el y ):_______ 
 
 
 
 
P R O VI D E R                 S u bj ect #:  
D at e: 
I n dic ati o n: 
T o ol us e d:  
  
Li N A 
o  
A d diti o n al t o ols us e d (t e n ac ul u m  ect ):  
  
SI S 
o  
T o ols us e d ( b all o o n c at h et er, t e n ac ul u m etc ):  

1 9  
 
 
A bilit y t o c o m pl et e pr oc e d ur e:  Y es/ N o  
W as t h er e p at h ol o gy vis u aliz e d: Y es/ N o                           S us p ect e d p at h ol o g y: ___________________ 
W as t h e p at h ol o g y a bl e t o b e r e m o v e d at t h e ti m e: Y es/ N o  
 
  
N ot at all 
s atisfi e d ( 1) 
S o m e w h at 
u ns atisfi e d  ( 2) 
N e utr al  ( 3) 
S o m e w h at  s atisfi e
d  ( 4)  
V ery s atisfi e d  ( 5) 
E as e of sc h e d uli n g  
 
  
  
  
  
  
A bilit y t o c o m pl et e 
t h e pr oc e d ur e 
 
 
 
 
 
Ut eri n e c a vit y 
ev al u ati o n  
 
 
 
 
 
 
A bilit y t o s e e a n d 
tr e at 
 
 
 
 
 
 
P erc eiv e d  p ai n or 
p ati e nt ex p eri e nc e   
  
  
  
  
  
T h e ti m e it t o ok t o 
c o m pl et e t h e 
pr oc e d ur e  
 
 
 
 
 
O v er all s atisf acti o n 
wit h t h e pr oc e d ur e  
  
  
  
  
  
 
E as e of us e of t o ol o n a sc al e of 1 -1 0 ( 1 b ei n g extr e m el y diffic ult a n d 1 0 b ei n g extr e m el y e asy): _ _ _ _ _ _ _  
Ti m e t o c o m pl et e pr oc e d ur e: _ _ _ _ _ _  
A n al g esi a us e d:  
Pr e m e dic ati o n ( Tyl e n ol, m otri n, b e nz o di az a p a m, ot h er): y es/ n o, s p ecif y _ _ _ _ _  
St aff i n v olv e d:  
A ny iss u es:  
 
Ar e a d diti o n al pr oc e d ur es n ec ess ar y ? _ _ _ _ _ _  
 
If s o w h at is t h e pl a n: _ _ _ _ _ _ _ _ _ _ W h at is t h e n ext a v ail a bl e d at e f or t his pl a n: _ _ _ _ _ _ _ _ _ _