Protocol Details
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
This study is currently recruiting participants.
Summary
Number |
000715-CH |
Sponsoring Institute |
National Institute of Child Health and Human Development (NICHD) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Female
Min Age: 4 Years
Max Age: 35 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Male;
Adults who are or may become unable to consent |
Keywords |
Ovarian Tissue Preservation;
Cancer Survivors And Infertility;
Acute Ovarian Failure In The Childhood Cancer Survivor Study;
Ovarian Failure After Radiation;
Natural History |
Recruitment Keyword(s) |
None |
Condition(s) |
Acute Ovarian Failure;
Infertility;
Early Menopause And Infertility In Females After Treatment For Childhood Cancer |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Child Health and Human Development |
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
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.
Citations:
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.
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.
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.
Contacts:
Clinical Trials Number:
NCT05440617