Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Phase: NA
Conditions: Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix), Myomectomy, Fallopian Tube Disease
Sponsor: Medstar Health Research Institute

PROTOCOL TITLE: MIGS ATOM Study 
 
 
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IRB Approved: April 7, 2025 
PROTOCOL TITLE: 
ATOM Study 
 
PRINCIPAL INVESTIGATOR: 
Alexis Dieter, MD 
 
Director of Research 
Section of Urogynecology & Reconstructive Pelvic Surgery 
MedStar Washington Hospital Center 
 
Associate Professor of OBGYN and Urology 
Georgetown University School of Medicine 
 
Office Number: 202-877-6526 
Email Address: alexis.a.dieter@medstar.net 
 
 
Table of Contents 
1.0 
Study Summary ....................................................................................................... 3 
2.0 
Objectives* ............................................................................................................. 4 
To assess the correlation between tubal patency and fibroid characteristics based on 
FIGO classification in patients undergoing surgery for uterine fibroids. ........................... 4 
To assess characteristics of patients who have change in tubal occlusion ......................... 4 
3.0 
Background* ........................................................................................................... 4 
4.0 
Study Endpoints* .................................................................................................... 6 
5.0 
Study Intervention/Investigational Agent ............................................................... 6 
6.0 
Procedures Involved* .............................................................................................. 6 
7.0 
Data and Specimen Banking* ................................................................................. 9 
8.0 
Sharing of Results with Subjects* .......................................................................... 9 
9.0 
Study Timelines* .................................................................................................... 9 
• 
May 2025: Begin patient enrollment/data collection .................................................. 9 
• 
April 2026: complete data collection, begin analysis ................................................. 9 
10.0 
Inclusion and Exclusion Criteria* ........................................................................... 9 
11.0 
Vulnerable Populations* ....................................................................................... 10 
12.0 
Local Number of Subjects .................................................................................... 10 
13.0 
Recruitment Methods ............................................................................................ 10 
14.0 
Withdrawal of Subjects* ....................................................................................... 10 
15.0 
Risks to Subjects* ................................................................................................. 10 
16.0 
Potential Benefits to Subjects* ............................................................................. 12 
17.0 
Data Management* and Confidentiality ............................................................... 12 
18.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects* ....................... 12 
18.1 
N/A. See sections 6.2 and 7.1 ............................................................................... 12 
19.0 
Provisions to Protect the Privacy Interests of Subjects ......................................... 12 
20.0 
Compensation for Research-Related Injury .......................................................... 13 
21.0 
Economic Burden to Subjects ............................................................................... 13 

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22.0 
Consent Process .................................................................................................... 13 
23.0 
Process to Document Consent in Writing ............................................................. 14 
24.0 
HIPAA Authorization ........................................................................................... 14 
25.0 
Setting ................................................................................................................... 15 
26.0 
Resources Available .............................................................................................. 15 
27.0 
Multi-Site Research* ............................................................................................ 15 
 
 
 

PROTOCOL TITLE: MIGS ATOM Study 
 
 
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1.0 
Study Summary 
 
Study Title 
Assessment of Tubal Occlusion During Minimally 
Invasive Myomectomy (ATOM) 
 
Study Design 
Single-arm prospective study 
Primary Objective 
Frequency of tubal occlusion in patients with fibroids 
immediately prior to and after completion of myomectomy  
Secondary 
Objective(s) 
 
● Tubal occlusion as compared to FIGO 
classification, size and anatomic location of 
fibroid(s)  
 
● Rate of change in tubal patency after completion 
of myomectomy (occluded to patent or patent to 
occluded)  
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Chromopertubation immediately prior to and at completion 
of myomectomy with dilute methylene blue dye solution 
IND/IDE #  
N/A 
Clinicaltrials.gov ID 
 
Study Population 
Patients undergoing laparoscopic or robotic myomectomy by 
a Minimally Invasive Gynecologic Surgery provider at 
MedStar 
Sample Size 
Goal to enroll at least 50 patients 
Study Duration for 
individual 
participants 
Less than 10 minutes of additional operative time during 
previously scheduled surgery 
Study Specific 
Abbreviations/ 
Definitions  
Chromopertubation: an established procedure that involves 
injecting a dilute solution of medical-grade dye into the 
endometrial cavity and visualizing spillage of the dye 
through the fallopian tubes into the abdominal cavity, 
indicating patency of the tubes. 
 
Myomectomy: surgery to remove uterine fibroids  
 
Myoma/leiomyoma: synonym for uterine fibroid 
 
 

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2.0 
Objectives* 
2.1 To evaluate the incidence of tubal occlusion in patients undergoing 
surgery for uterine fibroids before and after surgical intervention.  
 
To assess the correlation between tubal patency and fibroid characteristics 
based on FIGO classification in patients undergoing surgery for uterine 
fibroids.  
 
To assess characteristics of patients who have change in tubal occlusion  
 
2.2 Tubal occlusion will be observed in patients with fibroids. The 
frequency of tubal occlusion will change after myomectomy 
compared to pre-myomectomy.  
 
3.0 
Background* 
3.1 Fibroids have a prevalence >75%, making it the most common 
benign uterine disease [Zepiridis 2016, Lazaridis 2013, Giuliani 
2020].  Fibroids are well known to contribute to infertility and early 
pregnancy loss [Don 2023, Pritts 2025, Carson 2021, Giuliani 2020]. 
This is typically thought to be secondary to distortion and 
impairment of the endometrial cavity or myometrial junction. 
However, it has been stressed in recent reviews that the full 
mechanism of the effect of fibroids on infertility is not fully 
understood, and more studies are needed [Donnez 2024]. It is 
theorized but not well confirmed through evidence-based studies that 
fibroids may also occlude or compress fallopian tubes and contribute 
to tubal occlusion that may contribute to infertility [Don 2023, 
Zepiridis 2016, Horne 2007, Somigliana 2021]. Additionally, up to 
25-35% of female-factor infertility is related to tubal disease [ASRM 
Practice Committee 2021, Carson 2021, Mayrhofer 2022]. There is 
very little data on tubal patency assessment in patients undergoing 
myomectomy. A 2020 study compared frequency of tubal occlusion 
diagnosed by hysterosalpingogram to multiple variables, including 
fibroids, but was noted in subsequent reviews to be of poor quality 
and was specific to a low-resource setting in Cameroon [Egbe 2020, 
Somigliana 2021]. We have been able to identify only one 
prospective study from 1993 that specifically evaluated fallopian 
tube filling during post-myomectomy hysterosalpingogram, though 
the primary outcome of this study was endometrial cavity 
architecture [Lev-Toaff 1993]. A recent case report of removal of a 
particularly complex broad ligament fibroid describes the use of 
postoperative hysterosalpingogram, but did not utilize intraoperative 
chromopertubation [Sankey-Thomas 2024]. While this protocol may 

PROTOCOL TITLE: MIGS ATOM Study 
 
 
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be performed anecdotally in practice, empirical evidence for tubal 
evaluation before and after myomectomy is lacking.  
Chromopertubation under direct laparoscopic visualization is 
considered the “gold standard” for evaluation of tubal patency 
[Mayrhofer 2022, Mayrhofer 2024, Nako 2024, Saunders 2011, 
Carson 2021, ASRM Practice Committee 2021]. This is typically 
accomplished with dilute methylene blue or indigo carmine dye 
[Mayrhofer 2024]. 
3.2 Two recent retrospective studies have demonstrated a significant 
association between presence of leiomyoma and tubal occlusion in 
women with infertility [Mayrhofr 2024, Nako 2024]. Nako et al 
(2024) found a significant association only with submucosal fibroids. 
We have not identified any recent prospective studies evaluating 
tubal patency in patients with uterine leiomyoma or those 
undergoing myomectomy. Mayrhofr et al acknowledged this deficit 
in their 2024 retrospective study, stating that there is a “need for 
more studies on tubal patency epidemiology” and ultimately that 
“women with subfertility should undergo tubal patency testing early 
during infertility evaluation in order to not delay further treatment, 
particularly women with hydrosalpinges and myomas, as those were 
found to have the highest risk for occlusion.” In particular, the 
mechanism of proximal tubal occlusion is not yet well understood 
[Mayrhofer 2024]. Somigliana et al (2021) also emphasize that more 
studies on the effects of fibroids on natural fertility are “urgently 
needed.” 
A systematic review of the effects of fibroids on fertility found that 
only submucosal fibroids had a negative effect on fertility. However, 
that study did not specifically evaluate tubal patency, only included 
patients with diagnosed infertility, and did acknowledge that 
evidence for removal of intramural fibroids was of poor quality and 
further studies are needed [Pritts 2025]. Don et al (2023) 
acknowledge that more studies are needed on the effect of 
myomectomy on tubal function.  
3.3 Most data regarding tubal patency assessment are collected on 
patients already diagnosed with infertility, which introduces the 
possibility of multiple confounding variables. There are no recent 
prospective studies of tubal occlusion in patients with fibroids or 
patients undergoing myomectomy.  
Earlier detection of tubal disease may allow for a quicker and more 
proactive work up and counseling before other factors such as age 
and oocyte quality further impact fertility options. There is also 
limited data on tubal occlusion or patency in patients with fibroids 
and those undergoing myomectomy. Underappreciation of the effect 
of uterine fibroids and myomectomy on tubal patency and 

PROTOCOL TITLE: MIGS ATOM Study 
 
 
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subsequent delays in diagnosis could further complicate fertility due 
to age, reduced ovarian reserve and oocyte quality. Knowledge of 
tubal occlusion may influence referral to an infertility specialist or 
counseling for ectopic pregnancy risk.  
This proposed study can help contribute to a more proactive 
approach to early detection and intervention for tubal occlusion in a 
high-risk patient population in order to achieve the following goals: 
to improve understanding of the effects of fibroids and myomectomy 
on tubal occlusion and to gain a better understanding in order to 
inform future studies to optimize counseling, diagnosis, and early 
intervention for tubal occlusive disease  
 
4.0 
Study Endpoints* 
4.1 Patient enrollment from time of IRB approval until April 2026 with 
goal of enrolling at least 50 patients 
 
5.0 
Study Intervention/Investigational Agent 
5.1 Intervention: Chromopertubation, an established medical procedure 
used to evaluate fallopian tubal patency and infertility, will be 
performed immediately prior to and at completion of minimally 
invasive gynecologic surgery for fibroid removal (myomectomy). 
This procedure uses a solution of dilute methylene blue dye injected 
into the uterine cavity. 
5.2 Drug/Device Handling: no investigational drugs or devices are being used. 
Storage and handling of methylene blue dye and normal saline will be 
performed according to existing hospital protocols.  
5.3 N/A – No IND 
 
6.0 
Procedures Involved* 
6.1 This is a single-arm prospective study using chromopertubation to 
assess tubal occlusion in patients undergoing minimally invasive 
gynecologic surgery for uterine fibroids. This procedure involves 
injecting a dilute solution of medical-grade dye into the endometrial 
cavity and visualizing spillage of the dye through the fallopian tubes 
into the abdominal cavity, indicating patency of the tubes that would 
allow for spontaneous conception. Chromopertubation will be 
performed at the initiation and completion of the surgery and tubal 
occlusion will be documented.  
 
6.2 
Chromopertubation procedure: 

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o Pre-surgery: chromopertubation will be performed at the start of 
laparoscopic or robotic surgical procedure, once abdominal ports are in 
place and uterine manipulator placement has been performed prior to 
initiation of any myomectomy or other interventional surgical procedures.  
 
o Post-surgery: Chromopertubation will again be performed at the end of the 
surgery, once all surgical interventions are complete and prior to removal 
of abdominal ports and uterine manipulator.  
 
o Chromopertubation will be performed per standard clinical 
protocol as follows: Up to 50 mL of dilute methylene blue dye 
solution (1mL of 10 mg/mL 1% methylene blue in 200 mL normal 
saline) will be injected into the uterine cavity through a uterine 
manipulator with a patent central channel. This dose totals up to 
2.5 mg of dilute methylene blue dye per chromopertubation 
injection and an anticipated maximum dose of 5 mg of dilute 
methylene blue per patient. Spillage of dye should be visible 
immediately after injection of dilute dye into the endometrial 
cavity if tubes are patent.  
 
Adverse event monitoring:  
 
o As chromopertubation is an established medical procedure, patients will 
be monitored according to the standard intra-operative and post-operative 
criteria. If there are any signs of adverse events prior to completion of the 
study interventions, the study procedure will be aborted immediately and 
supportive therapy provided as needed. This will be done through 
communication between the surgical and anesthesiology teams.  
o Patients will be observed in the post-anesthesia care unit (PACU) 
according to standard postoperative protocol for any adverse events. In 
accordance with our standard post-operative practice, all patients will be 
discharged home upon meeting standard postoperative discharge criteria.  
As per routine standard protocol, all patients will be called at home to 
assess for any issues or concerns and to see how they are doing overall.  
This call is performed by either the attending surgeon or fellow on post-
operative day #1, if discharged after surgery, or rounded on if admitted to 
the hospital overnight.  

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o Patients who report adverse effects once at home will be triaged and 
evaluated according to standard post-operative precautions. 
 
• 
All patients will be monitored according to standard protocol 
for any intra-operative or post-operative adverse events.  
• 
The following medical supplies, drugs, and devices will be 
used: 
o The only components that will be used during this 
study that are exclusive to the investigation is the 
dilute methylene blue dye solution in normal saline. 
This is an approved medical dye that is commonly 
used for a variety of medical and surgical 
procedures and is administered via various routes 
(intravenous, instillation into bladder, uterus, etc.). 
No use during this study will be outside the 
standard usage protocol.  
o No additional medical devices outside of what is 
standard for the planned surgical procedure will be 
utilized for investigational purposes. The 
application of the methylene blue dye solution can 
be performed using the uterine manipulator that is 
already a standard instrument used during the 
surgical procedure.  
• 
Source records include the patient chart - including 
demographic data, medical and surgical history, radiologic 
imaging, clinical notes, and operative reports. 
6.3 The following data will be collected: 
• From chart review: 
o Age 
o Obstetric history 
o Gynecologic history  
o Preoperative imaging findings  
During study procedures intra-operatively:  
o Preoperative tubal patency or occlusion - unilateral vs 
bilateral, proximal vs distal 
o Postoperative tubal patency or occlusion - unilateral vs 
bilateral, proximal vs distal 
o Size, anatomic location and FIGO classification of fibroids 
removed 
 

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6.4 There are no plans for long-term follow up at this time. Any 
additional planned contact with study participants for research 
purposes will be submitted to the IRB through a protocol addendum.  
 
7.0 
Data and Specimen Banking* 
7.1 No specimens will be obtained. Data will be stored on the secured 
institutional OneDrive.  
 
8.0 
Sharing of Results with Subjects* 
8.1 As this study is not blinded, the patient may inquire about the results 
at any time. Results will be noted in the operative report.  
As no standard guidelines exist, patients for whom bilateral tubal 
occlusion was observed will be counseled of the following options 
for future tubal disease testing: 
(1) Outpatient tubal patency assessment at either 3 months 
after surgery or once pregnancy is desired if more than 3 
months after surgery. The minimum recommended interval 
between myomectomy and conception is 3 months to allow 
for myometrial healing.  
(2) Referral to a reproductive endocrinology and infertility 
specialist 
In the case of unilateral occlusion, standard clinical counseling for 
unilateral tubal impairment or absence will be provided.  
 
9.0 
Study Timelines* 
• 
The estimated date for the investigators to complete this study:  
• May 2025: Begin patient enrollment/data collection 
• April 2026: complete data collection, begin analysis 
• 
 
10.0 Inclusion and Exclusion Criteria* 
10.1 A HIPAA waiver was requested in order to enable trained IRB 
approved study team members to screen provider schedules and 
EMR patient charts for patients who meet study criteria. 
10.2 Inclusion criteria:  
o Patients over age 18 who are undergoing minimally invasive 
uterine-preserving gynecologic surgery for removal of 
uterine fibroids (myomectomy) by a minimally invasive 
gynecologic surgeon at MedStar.  

PROTOCOL TITLE: MIGS ATOM Study 
 
 
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Exclusion criteria:  
o Patients with both fallopian tubes absent 
o Patients in whom it is not possible to place a uterine manipulator or 
catheter 
o Patient with known tubal disease or occlusion, or patients who have 
undergone prior tubal surgery 
o Patients with allergy to methylene blue dye or G6PD deficiency 
o Patients with positive pregnancy test on day of surgery  
10.3 The following special populations will not be included: 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
11.0 Vulnerable Populations* 
11.1 N/A  
12.0 Local Number of Subjects 
12.1 We anticipate enrolling a minimum of 50 patients 
13.0 Recruitment Methods 
13.1 A member of the research team will reach out to the eligible patients 
for recruitment and consent. This may be done in person, via 
telehealth, or via phone call.  
13.2 The schedules of surgeons in the department of Minimally Invasive 
Gynecologic Surgery will be reviewed by a member of the research 
team and patients will be screened for inclusion criteria in this 
research study. A HIPAA waiver to review patient charts is 
requested for screening purposes.   
14.0 Withdrawal of Subjects* 
14.1 Subjects will be withdrawn without their consent under the following 
circumstances: the planned myomectomy is aborted for any reason, 
the subject demonstrates an adverse reaction to the methylene blue 
dye, or there are complications in the operating room for any reason 
that result in inability to safely complete the procedure. 
14.2 N/A 
14.3 This study includes a one-time intervention. No further data will be 
collected if a participant withdraws from study participation. Partial 
withdrawal is not applicable. 
15.0 Risks to Subjects* 

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Risks of Methylene Blue intrauterine instillation: low risk with rare 
risk of adverse events 
Use of sterile dilute methylene blue dye installation in the uterus and 
fallopian tubes is routine for performing chromopertubation and is 
widely considered safe and low risk. In addition to intrauterine 
injection, methylene blue dye is routinely used in solution to fill the 
bladder and check for injury, injected intravenously to evaluate 
ureteral patency during urinary excretion, and injected directly into 
tissue for sentinel lymph node identification [Bezu 2010, Ramin 
2011, Barbieri 2014]. Methylene blue dye has been safely used to 
perform chromopertubation since first introduced in 1968 [Ansari 
1968].  
There are reports of rare allergic reactions, including urticaria, 
anaphylaxis and pulmonary edema, to methylene blue dye. Another 
rare potential adverse effect is methemoglobinemia, which occurs 
when methylene is given in high doses or in patients with G6PD 
deficiency [Jena 2019, Bagadia 2017]. The maximum safe dosage is 
considered to be 7 mg/kg [Jena 2019, Bagadia 2017]. Several case 
studies of adverse effects are related to direct tissue injection of non-
dilute methylene blue dye, though reports of reactions after 
chromopertubation have been described [Akazawa 2019, Rzymski 
2023]. Our protocol will use an approximate total dose of 5 mg 
methylene blue dye in dilute solution, a low dose that is considered 
safe from systemic side effects [Barbieri 2014].  
 
Chromopertubation procedure: low risk 
Most risks of chromopertubation as compared to other methods of 
tubal patency assessment are the general and universal risks of 
undergoing surgery. However, in our study population, all patients 
are already undergoing medically-indicated surgery under general 
anesthesia for treatment and management of gynecologic pathology. 
Participation in this study for tubal assessment will not incur 
additional risks related specifically to surgery other than adding an 
estimated additional operative time of less than 10 minutes. 
Chromopertubation can typically be performed in 1-2 minutes.    
Other risks include emotional distress due to the results of the 
chromopertubation procedure and potential concerns about fertility.  
As with all studies that include access to PHI, there is a low risk of 
breach of confidentiality.  
15.1 As the study intervention is an established and commonly performed 
medical procedure, it is not thought to carry unforeseeable risks.  
15.2 N/A 

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15.3 Concerns about tubal disease and fertility associated with this study 
may confer stress onto the partners of study subjects.  
16.0 Potential Benefits to Subjects* 
16.1 Patients participating in this study will receive a gold-standard 
evaluation of tubal patency concurrently during surgery. For patients 
for whom tubal patency assessment would be indicated or desired, 
this study would avoid radiation exposure and discomfort during 
outpatient hysterosalpingogram. This evaluation may or may not be 
clinically relevant to an individual patient’s fertility or desired family 
planning outcomes.  
16.2 We cannot guarantee that there will be an immediate or long-term 
benefit to individual patients participating in the study. 
17.0 Data Management* and Confidentiality 
17.1 Data containing PHI will be kept confidential in a Microsoft Excel 
document stored in an electronic, password protected drive located 
on the institutional OneDrive. This database will be accessible only 
to IRB approved study team members. The data will be destroyed 
following study completion as per institutional requirements for 
human subject research.  
A de-identified database will be provided to the statistical team for 
data analysis.  
Consent forms will be available on paper and electronically. All 
electronic consent forms will be stored in a secure database for the 
duration of the study. Paper consent forms will be stored in a locked 
office for the duration of the study and then destroyed in accordance 
with PHI requirements.  
17.2 No specimens will be collected. Data will be handled as noted above 
in section 17.2. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
18.1 
N/A. See sections 6.2 and 7.1  
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 In order to protect subjects’ privacy interests, subjects will only 
interact with or provide personal information to members of the 
research team designated on the IRB during study introduction, 
recruitment, and consent. Otherwise, subjects will have standard 
interaction with their surgeon and the medical and surgical teams 
participating in their care.  
19.2 Subjects will be introduced to the research study once they have a 
definitive surgical plan. They will be assured that the study 
interventions include an established and commonly performed 

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surgical procedure and that no unapproved agents or protocols will 
be utilized. They will be informed that the study does not include 
any blinding or randomization, and they have the choice to request 
their results at any time. They may communicate directly and openly 
about the study with the members of the research team, including 
their surgeon.  
19.3 A HIPAA waiver is requested to screen patient charts for those 
meeting inclusion criteria on the surgeons’ EMR schedules. Subjects 
will be enrolled and consented before any additional information is 
collected. Members of the research team will collect data from chart 
review both before and after the study interventions.  
 
20.0 Compensation for Research-Related Injury 
20.1 N/A 
21.0 Economic Burden to Subjects 
21.1 N/A 
22.0 Consent Process 
22.1 We will be obtaining consent from all subjects enrolled in the study. 
Consent will only be obtained from English-speaking adults who are 
able to provide consent. A study team member will contact the 
potential participants by either phone, remote telehealth visit, or 
meet in person to discuss the study and answer all questions. 
Potential participants may elect to defer signing consent if they wish 
to take additional time to consider whether to enroll. During the 
recruitment process both the clinical providers and the research study 
team members will explain that participation will in no way affect 
the patient’s clinical care. Patients will be offered a paper or 
electronic consent to review. Electronic consents will be sent using 
the Interlace eConsent platform. During the consent process, the 
research team member obtaining consent will review the entire 
consent form with the patient, answer any/all questions to help 
ensure that the patient understands the steps involved in 
participation, and ask for understanding throughout the process to 
help ensure comprehension. After the consent form has been 
completely reviewed and the study process explained in full, if the 
patient reports they understand the consent form and elects to 
participate in the study, then consent will be obtained by electronic 
or written consent. Consent may be obtained by any of the persons 
listed on the IRB application, which may include the attending 
surgeon, fellow, or student member of the research team. 
Once identified as potentially eligible to participate a member of the 
research team will contact the patient to further discuss the study and 

PROTOCOL TITLE: MIGS ATOM Study 
 
 
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answer questions using a standard process. If the patient chooses to 
enroll, they will be consented. Consent may be obtained 
electronically or in person.  Once the consent is completed and 
eligibility is confirmed, participants will be enrolled in the study. 
If patients are not scheduled for a formal in-person visit, patients will 
be introduced to the study and consented prior to surgery in the pre-
operative area. Patients will be provided a copy of the signed study 
consent. Consent forms will be scanned or uploaded into the patient 
chart.  
Non-English Speaking Subjects 
• 
N/A 
Waiver or Alteration of Consent Process (consent will not be 
obtained, required information will not be disclosed, or the 
research involves deception) 
• 
N/A 
Subjects who are not yet adults (infants, children, teenagers) 
• 
N/A 
Cognitively Impaired Adults 
• 
N/A  
Adults Unable to Consent 
• 
N/A  
 
23.0 Process to Document Consent in Writing 
23.1 A written consent document will be used 
 
24.0 HIPAA Authorization 
24. Request for a Waiver of HIPAA Authorization: regardless of IRB review 
category, for a chart review study involving Protected Health Information (PHI) a 
Waiver of HIPAA Authorization for the use or disclosure of PHI needs to be 
requested and obtained.  The following elements from 45 CFR 164.512 (i) (1) (i) 
must be met for the IRB to waive the requirement: 
 

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24.1 
A waiver of HIPAA authorization is being requested solely for the 
purposes of screening patient charts and contacting patients for 
potential enrollment in this research study. All subsequent research 
activities will be performed with patient consent.  
24.1.1 The use or disclosure of protected health information 
during the screening and recruitment process of the 
research involves no more than minimal risk to privacy 
of individuals. 
 
25.0 Setting 
25.1 Research will be conducted at MedStar Health facilities. Screening 
and recruitment will be conducted at outpatient office locations used 
by minimally invasive gynecologic surgeons. Study interventions 
and procedures will be performed in MedStar hospital operating 
rooms. 
26.0 Resources Available 
26.1 This research will be conducted within the department of Minimally 
Invasive Gynecologic Surgery and will have access to the facilities, 
research staff, surgeons, and fellows in this department. Research 
assistance will be provided by students at Georgetown University 
School of Medicine, who are listed on the IRB application.  
• 
Funding for supplies will be provided by the institution.   
• 
The facilities for the study interventions will be the MedStar 
hospital operating rooms. Subjects will have access to ongoing 
follow up care by their surgeon.  
• 
All persons on the research team will be IRB-approved.  
27.0 Multi-Site Research* 
27.1 
N/A  
 
 
 
 
 
1. Akazawa M, Wu Y, Liu W. Allergy-like reactions to methylene blue following 
laparoscopic chromopertubation: A systematic review of the literature. Eur J Obstet 
Gynecol Reprod Biol. 2019;238:58–62. https://pubmed.ncbi.nlm.nih.gov/31112852/. 
Accessed Jan 14, 2025. doi: 10.1016/j.ejogrb.2019.03.019. 

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2. Ansari AH. Methylene blue test for assessment of tubal patency: A new and simple 
technique. Can Med Assoc J. 1968;99(4):182–184. 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1924344/. Accessed Jan 14, 2025. 
3. ASRM Practice Committee. Role of tubal surgery in the era of assisted reproductive 
technology: A committee opinion. Fertility and Sterility. 2021;115(5):1143–1150. 
https://www.sciencedirect.com/science/article/pii/S0015028221000844.. doi: 
10.1016/j.fertnstert.2021.01.051. 
4. Bagadia R, Kanabar V. Can laparoscopic chromopertubation with methylene blue dye 
cause anaphylactic reactions like pulmonary edema? WJOLS. 2017;10(2):51–53. 
http://www.jaypeejournals.com/eJournals/ShowText.aspx?ID=12080&Type=FREE&TY
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