Using Platelet Rich Plasma to Improve Endometrial Thickness in Infertile Women
Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial
This study is testing if using Platelet Rich Plasma can help women with thin uterine lining improve their chances of getting pregnant through IVF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Reproductive Medicine Associates of New Jersey Academic / other |
| Locations | 1 site (Basking Ridge, New Jersey) |
| Trial ID | NCT05538338 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of intrauterine infusion of Platelet Rich Plasma (PRP) in increasing endometrial thickness and improving IVF outcomes in women with a history of thin endometrium. Participants will be randomly assigned to receive either PRP or a placebo saline infusion in a double-blind, placebo-controlled design. Following the infusion, patients will undergo a frozen embryo transfer of a single euploid embryo as per standard procedures. The goal is to determine if PRP can enhance the chances of achieving a successful pregnancy in this specific population.
Who should consider this trial
Good fit: Ideal candidates are women with a history of at least two unsuccessful frozen embryo transfers and a diagnosed thin endometrial lining.
Not a fit: Patients who have not undergone at least two prior unsuccessful frozen embryo transfers or have certain uterine anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pregnancy rates for women with thin endometrium who have struggled with infertility.
How similar studies have performed: While the use of PRP in reproductive medicine is gaining interest, this specific application for thin endometrium is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basking Ridge, New Jersey
- Reproductive Medicine Associates of New Jersey — Basking Ridge, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Christine V Whitehead, BSN, RN
- Email: clinicalresearchteam@ivirma.com
- Phone: 19736562841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.