Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy

NCT05440617 | Recruiting

• 2 other identifiers: 10000715000715-CH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Infertility; Acute Ovarian Failure; Early Menopause And Infertility In Females After Treatment For Childhood Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• create a databank of human ovarian tissue

  Create a databank of human ovarian tissue to elucidate histology and function in human ovaries

  end of study

Secondary Outcomes (1)

• create a databank of human ovarian tissue to elucidate histology and function in human ovaries

  end of study

Study Arms (1)

Subjects Treated with Gonadotoxic therapy

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

Eligibility Criteria

• Age: 4 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who will undergo gonadotoxic treatment at NCI.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Patrizio P, Butts S, Caplan A. Ovarian tissue preservation and future fertility: emerging technologies and ethical considerations. J Natl Cancer Inst Monogr. 2005;(34):107-10. doi: 10.1093/jncimonographs/lgi023.

  PMID: 15784838 BACKGROUND

• Sklar CA, Mertens AC, Mitby P, Whitton J, Stovall M, Kasper C, Mulder J, Green D, Nicholson HS, Yasui Y, Robison LL. Premature menopause in survivors of childhood cancer: a report from the childhood cancer survivor study. J Natl Cancer Inst. 2006 Jul 5;98(13):890-6. doi: 10.1093/jnci/djj243.

  PMID: 16818852 BACKGROUND

• Chemaitilly W, Mertens AC, Mitby P, Whitton J, Stovall M, Yasui Y, Robison LL, Sklar CA. Acute ovarian failure in the childhood cancer survivor study. J Clin Endocrinol Metab. 2006 May;91(5):1723-8. doi: 10.1210/jc.2006-0020. Epub 2006 Feb 21.

  PMID: 16492690 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Veronica Gomez-Lobo, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Gomez-Lobo, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 1, 2022
• Study Start: July 22, 2022
• Primary Completion (Estimated): September 21, 2041
• Study Completion (Estimated): September 21, 2041
• Last Updated: June 5, 2026

Record last verified: 2026-06-03

Locations

US (1)