NCT03916978 Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women
| NCT ID | NCT03916978 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Genesis Athens Clinic |
| Condition | Infertility, Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-05-21 |
| 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 2019-05-21 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 restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.
Eligibility Criteria
Inclusion Criteria: * Age between 45-55 years old * Amenorrhea for at least 12 months * 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 * Previous POI diagnosis * Abnormal karyotype * Endometriosis * Adenomyosis * Fibroids and adhesions * Infections in reproductive system * Current or previous diagnosis of reproductive system cancer * 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
Agni Pantou, MD
PRINCIPAL INVESTIGATOR
Centre of Human Reproduction, Genesis Athens Clinic
Frequently Asked Questions
Who can join the NCT03916978 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 55 Years, studying Infertility, Female. 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 NCT03916978 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 NCT03916978 currently recruiting?
Yes, NCT03916978 is actively recruiting participants. Contact the research team at marasimopoulou@hotmail.com for enrollment information.
Where is the NCT03916978 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT03916978 clinical trial?
NCT03916978 is sponsored by Genesis Athens Clinic. The principal investigator is Agni Pantou, MD at Centre of Human Reproduction, Genesis Athens Clinic. The trial plans to enroll 100 participants.