NCT02825849

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Infertility
• Asherman's Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2016-07-07
• Last updated: 2021-02-09
• Results posted: 2021-02-09

Locations

1 site across 1 country: United States