Platelet Rich Plasma for Insufficient Endometrium

NCT05538338 | Recruiting

• 1 other identifier: RMA-2022-04
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.

Conditions

Infertility of Uterine Origin

Outcome Measures

Primary Outcomes (1)

• Endometrial Thickness during frozen embryo transfer

  peak endometrial thickness prior to initiation of progesterone

  during the proliferative phase of the frozen embryo transfer cycle

Secondary Outcomes (1)

• Sustained implantation rate

  approximately 9 weeks gestational age

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group

Other: Platelet Rich Plasma Intrauterine infusion

Control Group

PLACEBO COMPARATOR

an intrauterine infusion of normal saline will be administered to this group

Other: Normal saline Intrauterine infusion

Interventions

Platelet Rich Plasma Intrauterine infusion OTHER

an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants

Intervention Group

Normal saline Intrauterine infusion OTHER

an intrauterine infusion of normal saline will be administered to this group of participants

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who have previously undergone at least 2 unsuccessful frozen embryo transfer cycles, defined as failure to achieve a sustained clinical pregnancy (visualization of intrauterine gestational sac on ultrasound or a cancelled embryo transfer cycle due to inadequate endometrial thickness
• Patients with a diagnosis of thin endometrial lining (less than or equal to 6 mm maximum thickness) during prior unsuccessful or canceled embryo transfer cycles.

You may not qualify if:

• Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles.
• Most recent unsuccessful embryo transfer prior to January 1, 2017.
• Mullerian anomalies, excluding arcuate uterus
• Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery
• Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
• Failure of patient to agree to enrollment in study with written consent.
• Concurrent pregnancy
• Anticoagulation use for which plasma infusion is contraindicated
• History of thrombosis
• Thrombophilia either inherited or acquired
• Concomitant use of adjunctive therapies for proliferation. These must be discontinued upon enrollment.
• Embryo planned to be used for transfer generated from surgically obtained sperm due to a diagnosis of non-obstructive azoospermia
• Recurrent/persistent endometrial fluid in prior cycles

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Central Study Contacts

Christine V Whitehead, BSN, RN

CONTACT

19736562841; clinicalresearchteam@ivirma.com

Caroline Zuckerman, BS

CONTACT

19736562841; clinicalresearchteam@ivirma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 13, 2022
• Study Start: October 15, 2022
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)