NCT03937661 Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders
| NCT ID | NCT03937661 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Genesis Athens Clinic |
| Condition | Ovary; Anomaly |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-05-06 |
| Primary Completion | 2027-01-30 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2019-05-06 with a primary completion date of 2027-01-30.
⚠ 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
Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).
Eligibility Criteria
Inclusion Criteria: * Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following) * Age ≥ 40 years * AMH \< 1.1 ng/ml OR AFC \< 7 * ≤ 3 oocytes with a conventional stimulation protocol) * Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment. * Willing to comply with study requirements Exclusion Criteria: * Any pathological disorder related to reproductive system anatomy * Cycle irregularities * Amenorrhea * Endometriosis * Adenomyosis * Fibroids and adhesions * Infections in reproductive system * Current or previous diagnosis of cancer in reproductive system * History of familiar cancer in reproductive system * Severe male factor infertility * Prior referral for PGT * Ovarian inaccessibility -Endocrinological disorders (Hypothalamus- * Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome) * BMI\>30 kg/m2 or BMI\<18.5 kg/m2 * Systematic autoimmune disorders
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03937661 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 47 Years, studying Ovary; Anomaly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03937661 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03937661 currently recruiting?
Yes, NCT03937661 is actively recruiting participants. Contact the research team at marasimopoulou@hotmail.com for enrollment information.
Where is the NCT03937661 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT03937661 clinical trial?
NCT03937661 is sponsored by Genesis Athens Clinic. The trial plans to enroll 100 participants.