Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study
Phase: PHASE2
Conditions: Infertility, Asherman's Syndrome
Sponsor: University of California, San Francisco

Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair NCT02825849 
Document Date: Oct 25 2019 
Summary of PRP Study Protocol 
 
 

 
Study Period 1:  Randomized controlled trial:  
 
• 8 subjects randomized to PRP 
• 5 subjects randomized to control. 
•  
   Patients will be randomized to standard treatment procedures versus standard treatment plus 
intrauterine infusion of platelet rich plasma (PRP). Both groups of patients will receive the same 
initial workup, consultation and evaluation, treatment, surgical interventions or cycle monitoring, 
ultrasounds and embryo transfer. The only difference between the two groups will be the 
intrauterine infusion of PRP based on randomization and that the experimental group will have 
an extra blood draw for PRP preparation.     
 
 The only difference in clinical practice that the experimental group in this randomized 
controlled trial would have that differed from the "control" population, would be the 1-2 
intrauterine infusion of PRP based on randomization and that the experimental group will have 
an extra blood draw for PRP preparation. The standard of care procedures for patients with 
Asherman's Syndrome is as following.  
 
All patients will undergo the hysteroscopic procedure in the operating room under general 
anesthesia for resection of intrauterine adhesions. The degree of the adhesions will be rated by 
the physician performing the surgery using ASRM classification guidelines. The scar and 
adhesions will be resected with hysteroscopic scissors and grasper, until the endometrium 
appears to be reached with visualization of vascularity. Thereafter, a pediatric 8-10-gauge Foley 
catheter will be placed into the uterine cavity, and the balloon will be inflated with 3 ml of 
normal saline. The catheter extending out of the uterus will be tied off with 2 ties of 2'0' silk and 
then the catheter will be cut distally to the knots, with no parts extending outside of the vagina. 
Patients will be discharged home the same day and instructed to start on 30 days of 2 mg 
estradiol twice daily per usual protocol, with 10 days of medroxyprogesterone acetate 10mg 
daily for the last 10 days of estradiol. All patients will receive doxycycline antibiotic 100mg 
twice a day for the duration of the intrauterine Foley catheter placement (5-7 days). They will 
have endometrial lining assessment with transvaginal ultrasound 2 and 4 weeks during the first 
month post-procedure. Second look hysteroscopy will be performed after 1 month to assess the 
uterine cavity. Patients will be asked to record the menstrual flow diary before treatment and for 
the next 1-3 months (Menstrual Assessment Chart, from Higham et al, BJOG 1990). Future 
fertility treatment will be planned on individual bases per patients’ preferences. For the patients 
with thin endometrial lining, the standard of care guidelines for hormone replacement in the 
setting of frozen IVF cycles will be used as a reference (not a part of experimental protocol) 
chosen by the primary physician. The primary doctor will manage the entire hormone 
replacement based on the clinical knowledge, expertise and standard of care practices. 
Endometrial lining measured by ultrasound is recorded at every visit. Patients will be undergoing 
standard controlled frozen embryo transfer (FET) cycle and will be started on oral contraceptive 
pills (OCP, Desogen) to block the endogenous hormone production for 14-28 days, per usual 
protocol. GnRH agonist (Leuprolide acetate, Lupron) will be started for pituitary suppression 6-7 
days before the last OCP dose, subcutaneously at a dose of 10 units (0.5mg) daily, which will 
continue until start of progesterone. Patients will present for baseline ultrasound per standard 

practice on second day of menses after OCP withdrawal. If baseline ultrasound normal, patients 
will start Vivelle estradiol patch 0.1mg every 36 hours with increasing dose, again per standard 
protocol. Surveillance ultrasound lining check will be scheduled on cycle day 12. Per our 
standard protocol, minimal endometrial strip thickness of 7mm is required before initiation of 
progesterone. If patients meet the criteria for embryo transfer, it will be performed according to 
the standard of care. If the lining is thin, patient will be randomized to control or study group. 
7.11 INSTRUMENTS: List all questionn 
 
Study period 2 (10/2/2018):   
Prospective recruitment of patients opting for PRP (no randomization; all received 
intervention.).  
 
• 14 Subjects received PRP using the above protocol