Collecting ovarian tissue from young women undergoing fertility preservation before cancer treatment
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
This study is trying to collect ovarian tissue from young women aged 4 to 35 who are preserving their fertility before cancer treatment to learn more about ovarian health and reproductive outcomes for cancer survivors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 4 Years to 35 Years |
| Sex | Female |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05440617 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a databank of ovarian tissue from females aged 4 to 35 who are undergoing ovarian tissue cryopreservation (OTC) prior to gonadotoxic cancer treatments. Participants will have their medical records reviewed and will be asked to donate a portion of their ovarian tissue for research purposes. The study will focus on understanding the normal histology and function of human ovaries, as well as the short and long-term reproductive health outcomes for cancer survivors. Data collected will contribute to a national database to facilitate future research on complications and reproductive health parameters.
Who should consider this trial
Good fit: Ideal candidates are females aged 4 to 35 who are planning to undergo OTC before receiving gonadotoxic therapy.
Not a fit: Patients who are unable to provide informed consent due to psychological or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of ovarian function and improve fertility preservation strategies for young women facing cancer treatments.
How similar studies have performed: Other studies have shown promise in fertility preservation techniques, but this specific approach to creating a databank for ovarian tissue is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent/assent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Subjects who have planned to undergo OTC for gonadotoxic therapy based on current standard of care. EXCLUSION CRITERIA: -An individual who meets any of the following criteria will be excluded from participation in this study: --Adults subjects with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Veronica Gomez-Lobo, M.D. — Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study coordinator: Veronica Gomez-Lobo, M.D.
- Email: veronica.gomez-lobo@nih.gov
- Phone: (301) 435-7567
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.