Using autologous PRP infusion to restore ovarian function in patients with premature ovarian insufficiency
Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients
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 |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 39 Years |
| Sex | Female |
| Sponsor | Genesis Athens Clinic Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT04031456 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While PRP has shown promise in other medical fields, its efficacy in ovarian rejuvenation is still being explored, making this approach relatively novel.
Eligibility criteria
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 this trial is running
Athens
- Genesis AC — Athens, Greece (Recruiting)
Study contacts
- Study coordinator: Mara Simopoulou, PhD
- Email: marasimopoulou@hotmail.com
- Phone: +306979234100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.