Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy

Infertility Clinical Trial

Official title:

Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440617
• Other study ID #: 10000715
• Secondary ID: 000715-CH
• Status: Recruiting
• Start date: July 22, 2022
• Est. completion date: September 21, 2041

Study information

• Verified date: June 6, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Veronica Gomez-Lobo, M.D.
• Phone: (301) 435-7567
• Email: veronica.gomez-lobo[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study Description:

We will provide ovarian tissue cryopreservation (OTC) as a clinical service at NIH and collect a portion of the tissue for research regarding normal histology and function of the human ovary. In addition, de-identified data will be entered in a national database which will allow future research regarding short term and long term complications (Including impact of therapy on remaining ovarian function), as well as long term outcomes including reproductive health outcomes (including rate of tissue reimplantation and pregnancies)

Objectives:

Primary objective: is to create a databank of human ovarian tissue to elucidate histology and function in human ovaries.

Secondary objective: will be to populate a national database of individuals who have undergone OTC in order to elucidate short and long term outcomes including complications and reproductive health parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 21, 2041
• Est. primary completion date: September 21, 2041
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 4 Years to 35 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.

Related Conditions & MeSH terms

• Infertility
• Menopause, Premature
• Primary Ovarian Insufficiency

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	create a databank of human ovarian tissue to elucidate histology and function in human ovaries	Populate a national database of individuals who have undergone OTC in order to elucidate short and long term outcomes including complications and reproductive health parameters.	end of study

External Links

•   NIH Clinical Center Detailed Web Page