Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair (PRP-E)
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ClinicalTrials.gov Identifier: NCT02825849 |
Recruitment Status :
Completed
First Posted : July 7, 2016
Last Update Posted : March 27, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility Asherman's Syndrome | Biological: Intrauterine infusion of platelet rich plasma | Phase 2 |
BACKGROUND:
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
HYPOTHESIS:
Platelet rich plasma stimulates cellular processes involved in endometrial regeneration relevant to management of a thin lining or intrauterine scarring.
PRIMARY AIMS:
- To measure the change in endometrial lining thickness
SECONDARY AIMS:
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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:
- the chance of having embryo transfer,
- implantation rate
-
clinical pregnancy rate
2. In patients with Asherman's Syndrome, to determine:
- the rate of return/normalization of menses
- the chance of spontaneous pregnancy
- the chance of embryo transfer
Any adverse effects of study arm will be monitored and reported as appropriate.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Modified to nonrandomized allocation due to lack of patients willing to be randomized following initial enrollment period. 20 enrolled patients compared to 20 case-controls matched for thin lining and Asherman's syndrome. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 : | March 2019 |
Actual Study Completion Date : | March 2019 |

Arm | Intervention/treatment |
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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
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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
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- Endometrial thickness [ Time Frame: 3-30 days after treatment ]Endometrial thickness will be measured using transvaginal ultrasound per standard protocol
- Implantation rate (for patients with thin lining) [ Time Frame: approximately 7 weeks after treatment ]defined by number of gestational sacs seen on early pregnancy 6-week ultrasound divided by number of embryos transferred
- Clinical pregnancy rate (for patients with thin lining) [ Time Frame: approximately 7 weeks after treatment ]Defined by the number of fetal poles with heartbeat seen on 6-week ultrasound divided by the number of embryos transferred
- Return/normalization of menstrual flow (for patients with Asherman's Syndrome) [ Time Frame: 1-3 months after treatment ]Patients will be asked to record the menstrual flow diary (Menstrual Assessment Chart) before treatment and for 1-3 months after treatment

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Ages Eligible for Study: | 18 Years to 43 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Persistent thin lining < 6mm on >1 cycle in previous IVF or FET cycle OR moderate-to-severe Asherman's syndrome
Exclusion Criteria:
- Age <18 years old or >43 years old,
- Pregnancy,
- Diagnosis of cancer,
- Hb <11 g/dL, platelets <150,000/mm3,
- Anticoagulation,
- NSAIDs in the 10 days before procedure
- Any significant comorbidity or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
- Incision in the uterus: myomectomy; cesarean section

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 |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT02825849 |
Other Study ID Numbers: |
16-19764 |
First Posted: | July 7, 2016 Key Record Dates |
Last Update Posted: | March 27, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
endometrium thin uterine lining uterine scarring |
Infertility Gynatresia |