What this trial studies
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
Conditions in scope
- Menopause, Premature
- Menopause Related Conditions
- Menopausal Syndrome
- Premature Ovarian Failure
- Ovarian Failure, Premature
Interventions
- Autologous Platelet Rich Plasma (Biological) — Autologous PRP intra ovarian infusion
- Placebo-Platelet Free Plasma (Biological) — Autologous PFP intra ovarian infusion
Who can join
Women only · Ages 25 Years to 39 Years · Accepts healthy volunteers.
Inclusion criteria
- Age \< 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels \>25 IU/L recorded on two occasions \>4 weeks apart
- Normal Karyotype: 46, XX
- 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
- AMH \> 8 pmol/L
- 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
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Athens | Genesis AC | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: PHASE2, PHASE3
- Start date: 2019-07-30
- Primary completion: 2026-01-30
- Last update posted: 2024-12-24
- First posted: 2019-07-24
Sponsor & contact
Lead sponsor: Genesis Athens Clinic (Other)
Collaborators: National and Kapodistrian University of Athens
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Restoration of menstrual cycle (Three months)
Regular menstrual cycle - Serum FSH levels (Follow-up period of three months entailing monthly evaluation)
Serum FSH levels evaluated monthly for three consecutive months
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT04031456 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.