Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 25 to 39 Women only

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

PhasePhase2; Phase3
Study typeInterventional
Ages25 Years to 39 Years
SexWomen only
Enrollment100 (estimated)
SponsorGenesis Athens Clinic
Academic / other
Locations1 site (Athens)
StatusRecruiting
StartedJuly 30, 2019
Main results expectedJanuary 30, 2027
Study endsJuly 30, 2028
Registry record updatedJuly 8, 2026
Trial IDNCT04031456 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.