Using platelet rich plasma to improve ovarian response in women with poor fertility
Investigating the Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion on Improving Ovarian Functionality in Poor Ovarian Response Patients
PHASE2; PHASE3 · Genesis Athens Clinic · NCT05181748
This study is testing whether using platelet-rich plasma can help women with poor fertility respond better during their treatment and produce more eggs.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 35 Years to 47 Years |
| Sex | Female |
| Sponsor | Genesis Athens Clinic (other) |
| Locations | 1 site (Athens, Attica) |
| Trial ID | NCT05181748 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of autologous platelet rich plasma (PRP) intraovarian infusion to enhance ovarian response in women diagnosed with poor ovarian response (POR) during fertility treatments. The approach aims to restore the ovarian microenvironment by utilizing growth factors found in PRP, potentially improving the number of oocytes retrieved during stimulation cycles. The study will involve a large cohort of POR patients, focusing on their hormonal profiles and overall reproductive performance. It is designed as a non-randomized open-label intervention to gather comprehensive data on the efficacy of this treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 40 and above who meet the Bologna criteria for poor ovarian response.
Not a fit: Patients with anatomical reproductive system disorders, severe male factor infertility, or other significant reproductive health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve fertility outcomes for women with poor ovarian response.
How similar studies have performed: While limited data exists on the effectiveness of PRP in treating poor ovarian response, previous small cohort studies suggest potential benefits, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following): 1. Age ≥ 40 years 2. AMH \< 1.1 ng/ml OR AFC \< 7 3. ≤ 3 oocytes with a conventional stimulation protocol * Discontinuation of any complementary/adjuvant treatment including hormone replacement and acupuncture, for at least three months prior to recruitment. * Willing to comply with study requirements Exclusion Criteria: * Any pathological disorder related to reproductive system anatomy * Cycle irregularities * 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 Preimplantation Genetic Testing (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, Attica
- Genesis Athens Clinic — Athens, Attica, Greece (RECRUITING)
Study contacts
- Principal investigator: Agni Pantou, M.D — Genesis Athens Clinic
- Study coordinator: Agni Pantou, M.D
- Email: agni.pantou@genesisathens.gr
- Phone: +306974447702
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.
Conditions: Poor Response to Ovulation Induction, Infertility, Female, Ovarian Insufficiency, Ovarian Failure, Reproductive Sterility, Ovary, Anomaly, Autologous platelet rich plasma intraovarian infusion