Freezing ovarian tissue to help preserve fertility
Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen: A Study By The National Physicians Cooperative of the Oncofertility Consortium At Northwestern University
This study is testing whether freezing ovarian tissue can help women preserve their fertility for the future after having surgery to remove their ovaries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 41 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT00902720 on ClinicalTrials.gov |
What this trial studies
This study aims to provide women with an alternative method for preserving fertility by freezing ovarian tissue. Participants will undergo an oophorectomy, where one or both ovaries are surgically removed, and the ovarian tissue will be cryopreserved for future use. The study will also collect medical history information and follow participants until they decide to utilize their stored tissue for fertility purposes. Additionally, women who have previously undergone this procedure will be invited to join a research database.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-41 who are facing medical treatments that may lead to loss of ovarian function.
Not a fit: Patients who do not require surgery or treatment that affects ovarian function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance fertility preservation options for women undergoing treatments that threaten ovarian function.
How similar studies have performed: Other studies have shown promise in ovarian tissue cryopreservation, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Woman between the age of 18-41 years who will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy expected to result in permanent and complete loss of subsequent ovarian function or have a medical condition or malignancy that requires removal of all or part of one or both ovaries. * Patients may have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis are eligible if they have not received therapy that is viewed as likely to result in complete and permanent loss of ovarian function. * For patients undergoing elective removal of an ovary for fertility preservation only, have two ovaries. * Patients who already have stored cryopreserved ovarian tissue in a frozen state prior to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible for enrollment with informed consent. * Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services. Exclusion Criteria: * Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent. * Women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
Where this trial is running
Portland, Oregon
- Oregon Health and Sciences Universtiy — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: David M Lee, MD — Oregon Health and Sciences University
- Study coordinator: David M Lee, MD
- Email: leedavi@ohsu.edu
- Phone: 503-418-3700
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.