Using platelet-rich plasma to improve ovarian response in women with infertility
Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders
PHASE2; PHASE3 · Genesis Athens Clinic · NCT03937661
This study is testing if using a special treatment called platelet-rich plasma can help women with infertility have better chances of getting pregnant during certain fertility treatments.
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) |
| Trial ID | NCT03937661 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of autologous platelet-rich plasma (PRP) intra-ovarian infusion in enhancing ovarian tissue functionality and improving outcomes in fresh embryo transfer-ICSI cycles for women diagnosed with Poor Ovarian Response (POR). The study employs a triple-blind randomized controlled trial design to assess the impact of PRP, which is enriched with growth factors, on patients' hormonal profiles and overall fertility. By comparing the effects of PRP against a placebo, the trial aims to provide insights into the potential benefits of this innovative treatment approach for women facing infertility challenges.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 40 and older who meet the Bologna criteria for Poor Ovarian Response.
Not a fit: Patients with anatomical reproductive system disorders, severe male factor infertility, or significant endocrine disorders 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 the use of PRP has shown promise in other medical fields, its application in ovarian rejuvenation is still being explored, 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) * Age ≥ 40 years * AMH \< 1.1 ng/ml OR AFC \< 7 * ≤ 3 oocytes with a conventional stimulation protocol) * 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 * 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 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.
Conditions: Ovary, Anomaly, Infertility, Female