Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy

United States Department of Health and Human Services (HHS)

Status

Enrolling

Conditions

Acute Ovarian Failure

Infertility

Early Menopause And Infertility In Females After Treatment For Childhood Cancer

Study type

Observational

Funder types

NIH

Identifiers

NCT05440617

000715-CH

10000715

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

4 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.