Freezing ovarian tissue to help women at risk of losing fertility
Cryopreservation of Ovarian Tissue for Potential In Vitro Maturation or Autologous Transplantation
This study is testing if freezing ovarian tissue can help women at risk of losing their fertility due to cancer treatments or surgery have a chance to have children later on.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | N/A to 45 Years |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT01558544 on ClinicalTrials.gov |
What this trial studies
This study focuses on the cryopreservation of ovarian tissue to preserve fertility in women who are at risk of premature ovarian failure due to cancer treatments or surgical interventions. Participants will undergo a thorough preoperative assessment, including imaging and blood tests, to evaluate ovarian function and reserve. Depending on the findings, one or both ovaries may be surgically removed for cryopreservation. The goal is to develop techniques that allow for the maturation of immature eggs, enabling women to conceive a genetically related child in the future.
Who should consider this trial
Good fit: Ideal candidates are premenopausal females aged 0-45 who are undergoing treatments likely to cause premature menopause or ovarian failure.
Not a fit: Patients who are already experiencing menopause or who have not received medical clearance for surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide women at risk of infertility due to cancer treatments with the opportunity to conceive biologically related children.
How similar studies have performed: Other studies have shown promise in the field of ovarian tissue cryopreservation, indicating that this approach is gaining traction and may lead to successful outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Females 0-45 years of age who are premenopausal * Treatment plan that will likely result in premature menopause or premature ovarian failure * This includes patients receiving: * Cancer treatment with abdominal pelvic irradiation and/or high dose chemotherapy * Surgery that requires removal of ovaries for medical condition or disease, e.g. Prophylactic oophorectomy in BRCA patients * Patient is unable or unwilling to pursue fertility preservation by freezing oocytes or embryos. * Previous treatment for cancer is acceptable if patient still has ovarian function * Patient is medically stable enough to undergo surgery (cleared for anesthesia) Exclusion Criteria: * Patients not meeting the above criteria * Patients who have not received medical clearance from their physicians to undergo surgery * Patients already experiencing menopause.
Where this trial is running
New York, New York
- Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Glenn Schattman, MD — Weill Medical College of Cornell University
- Study coordinator: Rodriq E. Stubbs, NP
- Email: res2011@med.cornell.edu
- Phone: 646-962-3276
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.