Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair (PRP-E)
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| ClinicalTrials.gov Identifier: NCT02825849 |
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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
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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:
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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 |
| Allocation: | Randomized |
| 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) |
| 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 : | August 2019 |
| Actual Study Completion Date : | August 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 |
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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
- 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
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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 |
Documents provided by 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 |
| Results First Posted: | February 9, 2021 |
| Last Update Posted: | February 9, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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endometrium thin uterine lining uterine scarring |
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Infertility Gynatresia |