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

Infertility Clinical Trial

— PRP-E  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02825849
• Other study ID #: 16-19764
• Status: Terminated
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: August 2019

Study information

• Verified date: January 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Asherman's Syndrome
• Infertility

Intervention

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.

Locations

Country	Name	City	State
United States	University of California San Francisco - Center for Reproductive Health	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial Thickness	Endometrial thickness will be measured using transvaginal ultrasound per standard protocol	3-30 days after treatment
Secondary	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