Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair

Study Overview
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Brief Summary
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Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to standard therapies, present a significant clinical challenge. The aim of this trial is to assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial lining thickness in patients with thin lining or Asherman's Syndrome.

Detailed Description
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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: 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.

Official Title
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Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study

Conditions
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Infertility, Asherman's Syndrome

Intervention / Treatment
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* Biological: Intrauterine infusion of platelet rich plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP intrauterine infusion<br>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<br>* 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.<br>* Other names: PRP;|
| No Intervention: Control group with standard treatment only<br>Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial Thickness | Endometrial thickness will be measured using transvaginal ultrasound per standard protocol | 3-30 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Ultrasound Confirmed Clinical Pregnancies | Defined by ultrasound confirmed pregnancies per total participants in each arm | at least 7 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrium, thin uterine lining, uterine scarring