Improving ovarian tissue reimplantation with platelet-enriched plasma
Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
This study is testing if injecting a special type of blood plasma into the ovaries can help women with early menopause or irregular periods have better results after getting their frozen ovarian tissue transplanted.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06261658 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of injecting autologous platelet-enriched plasma into the ovaries during the transplantation of cryopreserved ovarian tissue. The goal is to enhance the outcomes of this procedure for women experiencing premature ovarian failure or irregular menstrual cycles. Participants will undergo a thorough screening process to ensure eligibility, including tests for infections and neoplastic contamination. The study aims to improve ovarian endocrine function and increase the chances of live births following transplantation.
Who should consider this trial
Good fit: Ideal candidates include women seeking cryopreserved ovarian tissue transplantation due to premature ovarian failure or irregular menstrual cycles.
Not a fit: Patients with neoplastic contamination in their ovarian tissue or significant endocrinological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve fertility outcomes for women with ovarian failure.
How similar studies have performed: While this specific approach is novel, similar studies involving platelet-rich plasma in other medical applications have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * request for cryopreserved ovarian tissue transplantation; * premature ovarian failure or irregular mentrual cycles; * negative test for HIV, HBV, HCV, Treponema pallidum; * negative PAP test; * oncological authorization; * absence of neoplastic contamination in the cryopreserved ovarian tissue; * Informed consent Exclusion Criteria: * neoplastic contamination in cryopreserved ovarian tissue; * history of endometriosis; * endocrinological disorders present and not treated (uncompensated thyroid dysfunction, diabetes (type 1, type 2); * body mass index (BMI) \>30 kg/m2; * circulating platelet level \< 150,000 / mml; * bacterial infection; * ongoing use of anticoagulants; * bleeding diathesis.
Where this trial is running
Bologna, BO
- Diego Raimondo — Bologna, Bo, Italy (Recruiting)
Study contacts
- Study coordinator: Diego Raimondo, MD
- Email: die.raimondo@gmail.com
- Phone: 0512143732
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.