Recruiting

Platelet Rich PlasmaPlatelet Rich Plasma for Insufficient Endometrium

Sponsor:

Reproductive Medicine Associates of New Jersey

Code:

NCT05538338

Conditions

Infertility of Uterine Origin

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Platelet Rich Plasma Intrauterine infusion

Normal saline Intrauterine infusion

Study Details

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

Study ID

NCT05538338

Start date

Oct 15, 2022

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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
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

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention Group

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

placebo comparator: Control Group

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

Interventions

Platelet Rich Plasma Intrauterine infusion

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

Normal saline Intrauterine infusion

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

Primary outcome measure

Endometrial Thickness during frozen embryo transfer [ Time Frame: during the proliferative phase of the frozen embryo transfer cycle ]

Central Contacts and Locations

Central contacts

Christine V Whitehead, BSN, RN

19736562841 clinicalresearchteam@ivirma.com

Caroline Zuckerman, BS

19736562841 clinicalresearchteam@ivirma.com

Locations

Reproductive Medicine Associates of New Jersey

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Christine V Whitehead, BSN, RN

19736562841 cwhitehead@ivirma.com

Caroline Zuckerman, BS

19736562841 clinicalresearchteam@ivirma.com

Principal Investigator:

Jason Franasiak, MD

More Information

Sponsor

Reproductive Medicine Associates of New Jersey

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reproductive Medicine Associates of New Jersey on 2026-06-03.