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Summary

Eligibility
for females ages 18–43
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator
Heather G. Huddleston

Description

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.

Official Title

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

Details

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:
  • the chance of having embryo transfer,
  • implantation rate
  • clinical pregnancy rate

    1. 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.

Keywords

Infertility Asherman's Syndrome endometrium thin uterine lining uterine scarring

Eligibility

You can join if…

Open to females ages 18–43

  • Persistent thin lining < 6mm on>1 cycle in previous IVF or FET cycle OR moderate-to-severe Asherman's syndrome

You CAN'T join if...

  • 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

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02825849
Phase
Phase 2
Lead Scientist
Heather G. Huddleston
Study Type
Interventional
Last Updated
November 1, 2016
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