NCT03951194 Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women
| NCT ID | NCT03951194 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Genesis Athens Clinic |
| Condition | Infertility, Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-06-13 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 2019-06-13 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 and women's hormonal profile and may promote folliculogenesis in perimenopausal women.
Eligibility Criteria
Inclusion Criteria: * Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels. * 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 * 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 * Previous POI diagnosis -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
STUDY DIRECTOR
Obstetrician Gynecologist
Frequently Asked Questions
Who can join the NCT03951194 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 50 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 NCT03951194 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 NCT03951194 currently recruiting?
Yes, NCT03951194 is actively recruiting participants. Contact the research team at marasimopoulou@hotmail.com for enrollment information.
Where is the NCT03951194 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT03951194 clinical trial?
NCT03951194 is sponsored by Genesis Athens Clinic. The principal investigator is Agni Pantou, MD at Obstetrician Gynecologist. The trial plans to enroll 100 participants.