Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair (PRP-E)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02825849|
Recruitment Status : Terminated (Low recruitment and competing studies have published.)
First Posted : July 7, 2016
Results First Posted : February 9, 2021
Last Update Posted : February 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Infertility Asherman's Syndrome||Biological: Intrauterine infusion of platelet rich plasma||Phase 2|
There is a need for new and more effective therapies for patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly for patients resistant to standard therapies
Platelet rich plasma stimulates cellular processes involved in endometrial regeneration relevant to management of a thin lining or intrauterine scarring.
- To measure the change in endometrial lining thickness
To determine if fertility is improved in patients receiving platelet rich plasma (PRP):
1. In patients with thin lining undergoing frozen embryo transfer (FET), to determine:
clinical pregnancy rate
2. In patients with Asherman's Syndrome, to determine:
- the chance of spontaneous pregnancy
Any adverse effects of study arm will be monitored and reported as appropriate.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
During Study Period #1: Subjects were randomized to receive either PRP or standard care. A total of 13 subjects were randomized.
The study design was then altered to remove randomization (10/4/2018). All patients in Study Period #2 received PRP. An additional 14 subjects were enrolled in Study Period #2.
|Masking:||None (Open Label)|
|Official Title:||Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||August 2019|
Experimental: PRP intrauterine infusion
Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles
Biological: Intrauterine infusion of platelet rich plasma
Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.
Other Name: PRP
No Intervention: Control group with standard treatment only
Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols
- Endometrial Thickness [ Time Frame: 3-30 days after treatment ]Endometrial thickness will be measured using transvaginal ultrasound per standard protocol
- Number of Participants With Ultrasound Confirmed Clinical Pregnancies [ Time Frame: at least 7 weeks after treatment ]Defined by ultrasound confirmed pregnancies per total participants in each arm
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825849
|United States, California|
|University of California San Francisco - Center for Reproductive Health|
|San Francisco, California, United States, 94158|
|Principal Investigator:||Heather G. Huddleston, MD||University of California, San Francisco|