PIER: Platelet Rich Plasma for Insufficient Endometrium: a Randomized Controlled Trial

Sponsor

Reproductive Medicine Associates of New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05538338

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility of Uterine Origin	Other: Platelet Rich Plasma Intrauterine infusion Other: Normal saline Intrauterine infusion	N/A

Detailed Description

Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Group an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group	Other: Platelet Rich Plasma Intrauterine infusion an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants
Placebo Comparator: Control Group an intrauterine infusion of normal saline will be administered to this group	Other: Normal saline Intrauterine infusion an intrauterine infusion of normal saline will be administered to this group of participants

Arm

Intervention/Treatment

Active Comparator: Intervention Group

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

Other: Platelet Rich Plasma Intrauterine infusion

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

Placebo Comparator: Control Group

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

Other: Normal saline Intrauterine infusion

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

Outcome Measures

Primary Outcome Measures

Endometrial Thickness during frozen embryo transfer [during the proliferative phase of the frozen embryo transfer cycle]
peak endometrial thickness prior to initiation of progesterone

Secondary Outcome Measures

Sustained implantation rate [approximately 9 weeks gestational age]
presence of fetal heart beat upon discharge from care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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
Submucosal fibroids
History of uterine surgery, excluding polypectomy, D&C, lysis of adhesions and Cesarean section
Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
Failure of patient to agree to enrollment in study with written consent.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey	United States	07920

Sponsors and Collaborators

Reproductive Medicine Associates of New Jersey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Reproductive Medicine Associates of New Jersey

ClinicalTrials.gov Identifier:

NCT05538338

Other Study ID Numbers:

RMA-2022-04

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Sep 13, 2022