Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Jun 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how to help young women preserve their ability to have children after cancer treatment, which can sometimes cause infertility. The trial is specifically looking at a procedure called ovarian tissue cryopreservation (OTC), where a sample of ovarian tissue is frozen before treatment. This tissue contains immature egg cells that can be thawed and reimplanted later, potentially allowing women to become pregnant in the future. The National Institutes of Health (NIH) is conducting this study to create a database that collects information and samples from these women to aid in future research.

To be eligible for this study, participants need to be females aged 4 to 35 who are planning to undergo OTC before cancer treatment. They will need to give consent and be willing to follow the study procedures for its duration. Participants can expect to have their medical records reviewed, answer a questionnaire about their health and fertility treatments, and donate a small portion of their ovarian tissue for research. This survey will take about 30 minutes and will be repeated once a year for 30 years to gather ongoing information about their health and fertility. The data collected will be kept private and used to improve understanding of fertility preservation after cancer treatment.

Gender

FEMALE

Eligibility 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.