Transplanting ovarian tissue to restore fertility after cancer treatment
Autologous Ovarian Tissue Transplantation
This study tests whether transplanting frozen ovarian tissue can help women who have lost their fertility after cancer treatment regain their ovarian function and ability to conceive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT03496636 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of autologous ovarian tissue transplantation in women diagnosed with primary ovarian insufficiency following chemotherapy or radiation. Participants will have previously cryopreserved ovarian cortical tissue thawed and surgically transplanted. The study includes a series of follow-up assessments during the first two years post-transplantation, along with annual surveys thereafter to monitor outcomes. The aim is to evaluate the potential for restoring ovarian function and fertility in these patients.
Who should consider this trial
Good fit: Ideal candidates are women with primary ovarian insufficiency who have previously cryopreserved ovarian tissue and are cleared for pregnancy by their oncologist.
Not a fit: Patients who are high risk for surgical complications or have contraindications for pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help restore fertility in women who have experienced infertility due to cancer treatments.
How similar studies have performed: Other studies have shown promising results with similar approaches to ovarian tissue transplantation, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Previously cryopreserved ovarian tissue * Ovarian insufficiency and/or candidate for pregnancy * Good health * Oncologist's clearance Exclusion Criteria: * Patients considered to be high risk for surgical complications * Women with contraindication for pregnancy if goal is to achieve pregnancy * Women positive for the BRCA mutations * Women with a history of leukemia, ovarian cancer or a cancer that likely involved ovaries at the time of ovarian tissue collection * Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent * Current pregnancy
Where this trial is running
Pittsburgh, Pennsylvania
- Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kyle Orwig, PhD — University of Pittsburgh/University of Pittsburgh Medical Center
- Study coordinator: Jennifer Anglin
- Email: fertilitypreservation@upmc.edu
- Phone: 412-641-7475
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.