Transplanting frozen ovarian tissue to restore fertility
Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue
This study is testing if transplanting frozen ovarian tissue can help women who have lost their fertility due to cancer treatments have children again.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | Chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT01870752 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of transplanting previously frozen ovarian tissue in women who have become infertile or have ovarian insufficiency due to cancer treatments like chemotherapy and radiation. The research is conducted at the Abramson Cancer Center at the University of Pennsylvania, where patients who meet specific criteria will undergo this experimental procedure. The goal is to assess whether this approach can help restore fertility in affected women.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 45 who have previously stored ovarian tissue and are experiencing infertility or ovarian insufficiency.
Not a fit: Patients who are high risk for surgical complications or have certain cancers or genetic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide a new option for women to regain their fertility after cancer treatment.
How similar studies have performed: Other studies have shown promising results with ovarian tissue transplantation, suggesting this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patient between the ages of 18 and 45 years * Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation * Ovarian insufficiency defined as an elevated FSH over 10 * Inability to conceive after 6 months of unprotected intercourse with male * Reasonably good health * Candidate for pregnancy * Written clearance for the procedure from the patients oncologist Exclusion Criteria: * Patients considered to be high risk for surgical complications will be excluded from the research protocol * Women who are known to be positive for the BRCA mutation * Women with a history of leukemia, ovarian cancer or a cancer that likely involved the 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
Philadelphia, Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Clarisa R Gracia, MD — Abramson Cancer Center at Penn Medicine
- Study coordinator: Clarisa Gracia, MD
- Email: PennCancerTrials@emergingmed.com
- Phone: 877-204-9213
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.