RecruitingNCT05440617

Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy


Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Enrollment

100 participants

Start Date

Jul 22, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

Background: Medical advances have improved survival rates for many cancers and other illnesses. This means that more people are coping with the long-term effects of these treatments. Some treatments can cause female infertility. Ovarian tissue cryopreservation (OTC) may help. Before undergoing a treatment that may damage their fertility, patients may opt to freeze a sample of ovarian tissue. The tissue contains immature egg cells. When thawed, the tissue can be reimplanted. This procedure can help women become pregnant. Objective: This natural history study will create a databank of ovarian tissue. The NIH will provide OTC as a clinical service. The NIH will also request a portion of the tissue to use for research. Eligibility: Females aged 4 to 35 who opt to have OTC before receiving cancer treatment. Design: Participants will be screened. Their existing medical records will be reviewed. They will be asked if they want to donate a portion of their ovarian tissue for research. No more than 20% of the tissue collected will be taken for research. Some other tissues that would otherwise be discarded will also be kept. Medical data from each participant may also be collected and stored in the database. This data may include results of routine blood tests, imaging tests, and other information. The data will be coded for privacy. Participants will answer a questionnaire. They will be asked about their fertility treatment and general health. The survey takes about 30 minutes. They will repeat the questionnaire once a year for 30 years. ...


Eligibility

Sex: FEMALEMin Age: 4 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is creating a collection (biorepository) of tissue samples from people who are having ovarian tissue removed and frozen before receiving treatments that could harm their fertility (called gonadotoxic therapy). The samples will help researchers better understand fertility preservation. **You may be eligible if...** - You are scheduled to have ovarian tissue removed and frozen (ovarian tissue cryopreservation) before a medical treatment that could affect your fertility - You are willing and able to follow the study procedures for its full duration - You can provide signed informed consent **You may NOT be eligible if...** - You have psychological or psychiatric conditions that prevent you from fully understanding and consenting to the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05440617


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