ClinicalTrials.gg
RecruitingNCT05538338PIERUpdated Jun 3, 2026

Platelet Rich Plasma for Insufficient Endometrium

An interventional study of Platelet Rich Plasma Intrauterine infusion and Normal saline Intrauterine infusion in Infertility of Uterine Origin, sponsored by Reproductive Medicine Associates of New Jersey. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Reproductive Medicine Associates of New Jersey · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility of Uterine Origin

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03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's planned enrollment of 62 is below the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reproductive Medicine Associates of New Jersey is the lead sponsor of 55 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
62 participants (estimated)

Study arms

  • Active comparator
    Intervention Group

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

    Other: Platelet Rich Plasma Intrauterine infusion

  • Placebo comparator
    Control Group

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

    Other: Normal saline Intrauterine infusion

Interventions

  • OtherPlatelet Rich Plasma Intrauterine infusion

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

  • OtherNormal saline Intrauterine infusion

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

06

What researchers measure

Primary outcomes

  1. Endometrial Thickness during frozen embryo transfer

    peak endometrial thickness prior to initiation of progesterone

    Time frame: during the proliferative phase of the frozen embryo transfer cycle

Secondary outcomes

  1. Sustained implantation rate

    presence of fetal heart beat upon discharge from care

    Time frame: approximately 9 weeks gestational age

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05538338
Lead sponsor
Reproductive Medicine Associates of New Jersey
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
Oct 15, 2022
Primary completion
Oct 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 3, 2026

Study contacts

Christine V Whitehead, BSN, RN
Contact
clinicalresearchteam@ivirma.com
19736562841
Caroline Zuckerman, BS
Contact
clinicalresearchteam@ivirma.com
19736562841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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