NCT05538338 Platelet Rich Plasma for Insufficient Endometrium
| NCT ID | NCT05538338 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Reproductive Medicine Associates of New Jersey |
| Condition | Infertility of Uterine Origin |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2022-10-15 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2022-10-15 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05538338 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Infertility of Uterine Origin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05538338 currently recruiting?
Yes, NCT05538338 is actively recruiting participants. Contact the research team at clinicalresearchteam@ivirma.com for enrollment information.
Where is the NCT05538338 trial being conducted?
This trial is being conducted at Basking Ridge, United States.
Who is sponsoring the NCT05538338 clinical trial?
NCT05538338 is sponsored by Reproductive Medicine Associates of New Jersey. The trial plans to enroll 62 participants.