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Recruiting

NCT Number: NCT05440617

Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy

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.

Recruiting

Interested in participating?

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Key information

Conditions

Acute Ovarian Failure Early Menopause And Infertility In Females After Treatment For Childhood Cancer Genital Diseases Infertility Urogenital Diseases

Age range

4 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

800-411-1222 ext. TTY dial 711

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. create a databank of human ovarian tissue

    Time frame: end of study

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

Secondary outcomes

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

    Time frame: end of study

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Veronica Gomez-Lobo, M.D.

CONTACT

[email protected]

(301) 435-7567

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Important dates

Study start
2022
Primary completion
2041
Study completion
2041
First posted
Jul 1, 2022
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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