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

NCT02825849 | Terminated Phase 2 Results DMC

• 1 other identifier: 16-19764
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility; Asherman's Syndrome

Keywords

endometrium; thin uterine lining; uterine scarring

Outcome Measures

Primary Outcomes (1)

• Endometrial Thickness

  Endometrial thickness will be measured using transvaginal ultrasound per standard protocol

  3-30 days after treatment

Secondary Outcomes (1)

• Number of Participants With Ultrasound Confirmed Clinical Pregnancies

  at least 7 weeks after treatment

Study Arms (2)

PRP intrauterine infusion

EXPERIMENTAL

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

Control group with standard treatment only

NO INTERVENTION

Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols

Interventions

Intrauterine infusion of platelet rich plasma BIOLOGICAL

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.

Also known as: PRP

PRP intrauterine infusion

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco - Center for Reproductive Health

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Infertility; Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Limitations and Caveats

The study was a pilot study and was not adequately powered to detect a difference. In addition the study was closed prior to full enrollment.

Results Point of Contact

• Title: Heather Huddleston
• Organization: UCSF

heather.huddleston@ucsf.edu

415-353-3040

Study Officials

• Heather G. Huddleston, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2016
• First Posted: July 7, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 9, 2021
• Results First Posted: February 9, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)