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NCT Number: NCT02646384

Ovarian Tissue Cryopreservation in Children

The Institutional Review Board (IRB) protocol is being designed to offer ovarian tissue cryopreservation to female pediatric patients (birth-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential. Because this procedure is currently considered experimental, the establishment of an IRB protocol under which this opportunity can be offered is needed.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

Up to 17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

Ovarian tissue cryopreservation is currently considered experimental but offers the only opportunity for fertility preservation in pre-menarchal girls faced with a fertility threatening diagnosis or treatment plan.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(All inclusion criteria must be met.)

  • Female, age birth-17 years
  • Meet at least one of the following three conditions:
  • Have a diagnosis of a medical condition that is expected to result in permanent diminished or complete loss of subsequent ovarian function (e.g. Turner's syndrome) OR have a diagnosis that will create a need for surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of the condition (e.g lupus nephritis) or malignancy and is expected to result in permanent diminished or complete loss of subsequent ovarian function. Unlike in males where a semen analysis provides an objective measure of testicular function, ovarian reserve testing remains subjective by evaluation of hormones. Therefore, to objectively qualify a degree of expected diminished loss of fertility is difficult.
  • Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries. Girls with ovarian or germ cell tumors requiring removal of all or part of one or both ovaries will also be eligible for inclusion in the study.
  • Or, have a newly diagnosed or recurrent disease affecting fertility.
  • For patients undergoing elective removal of all or part of an ovary for fertility preservation only, they must have two ovaries.
  • Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.

Exclusion criteria

(Any exclusion criteria will disqualify.)

  • Girls with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
  • Girls whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
  • Subjects with extensive disease whose therapy is deemed palliative by the medical oncologist will not be selected.
  • Subjects with suspected severe diminished ovarian reserve, such as a follicle stimulating hormone (FSH) level of > 15.

Treatment and study plan

Ovarian tissue cryopreservation

Procedure

Ovarian tissue will be removed

Primary outcomes

  1. Number of pregnancy and live births after transplantation of cryopreserved ovarian tissue

    Time frame: 10-20 years

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen

Important dates

Study start
2017
Primary completion
2040
Study completion
2040
First posted
Jan 5, 2016
Registry last updated
Apr 20, 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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