Using autologous PRP infusion to restore ovarian function in patients with premature ovarian insufficiency
Official title: Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients
Run by Genesis Athens Clinic · NCT04031456 · Data updated 2026-11-12
This study is testing whether using a treatment made from a patient’s own blood can help women with premature ovarian insufficiency regain ovarian function and improve their hormone levels.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 39 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Genesis Athens Clinic Academic / other |
| Locations | 1 site (Athens) |
| Status | Recruiting |
| Started | July 30, 2019 |
| Main results expected | January 30, 2027 |
| Study ends | July 30, 2028 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT04031456 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women under 40 years old with amenorrhea or irregular menstrual cycles and elevated FSH levels indicating premature ovarian insufficiency.
✕Probably not a fit
Patients with anatomical reproductive system disorders, certain hormonal disorders, or those with a BMI outside the specified range may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of autologous platelet-rich plasma (PRP) infusion in restoring ovarian function and promoting folliculogenesis in patients with premature ovarian insufficiency (POI). The study employs a triple-blind randomized controlled trial design, where participants receive either the PRP treatment or a placebo. PRP is derived from the patient's own blood and contains growth factors that may stimulate tissue growth and repair. The trial aims to assess the impact of this treatment on hormonal profiles and ovarian functionality in affected individuals.
Why it matters
Potential benefit: If successful, this treatment could potentially restore ovarian function and improve hormonal balance in women with premature ovarian insufficiency.
How similar studies have gone: While PRP has shown promise in other medical fields, its efficacy in ovarian rejuvenation is still being explored, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 * 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
Where it's running
-
Genesis AC
Athens, Greece Recruiting
Study contacts
- Study coordinator: Mara Simopoulou, PhD
- Email: marasimopoulou@hotmail.com
- Phone: +306979234100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.