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

Phase 2TerminatedNCT02825849

University of California, San Francisco27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility Asherman's Syndrome

Interventions

Intrauterine infusion of platelet rich plasmaBIOLOGICAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 43 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of California San Francisco - Center for Reproductive Health

San Francisco, California, United States

Outcomes

Primary Outcomes

Endometrial Thickness

Endometrial thickness will be measured using transvaginal ultrasound per standard protocol

Time frame: 3-30 days after treatment

Secondary Outcomes

Number of Participants With Ultrasound Confirmed Clinical Pregnancies

Defined by ultrasound confirmed pregnancies per total participants in each arm

Time frame: at least 7 weeks after treatment

Data from ClinicalTrials.gov

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