Recruiting

Biorepository

Sponsor:

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

Code:

NCT05440617

Conditions

Acute Ovarian Failure

Infertility

Early Menopause And Infertility In Females After Treatment For Childhood Cancer

Eligibility Criteria

Sex: Female

Age: 4 - 35

Healthy Volunteers: Not accepted

Study Details

Brief 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.

...

Conditions

Acute Ovarian Failure

Infertility

Early Menopause And Infertility In Females After Treatment For Childhood Cancer

Study ID

NCT05440617

Start date

Jul 22, 2022

Status verified date

Jun 3, 2026

Completion date

Sep 21, 2041

Anticipated

Primary completion date

Sep 21, 2041

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 4 - 35

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects Treated with Gonadotoxic therapy

Subjects who have planned to undergo OTC for gonadotoxic therapy based on current standard of care.

Primary outcome measure

  • create a databank of human ovarian tissue [ Time Frame: end of study ]

Central Contacts and Locations

Central contacts

Veronica Gomez-Lobo, M.D.

(301) 435-7567veronica.gomez-lobo@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

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

Last update posted

Sep 8, 2026

Last verified

Jun 3, 2026

Keywords

  • Ovarian Tissue Preservation
  • Cancer Survivors And Infertility
  • Acute Ovarian Failure In The Childhood Cancer Survivor Study
  • Ovarian Failure After Radiation
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2026-09-08.