Ovarian Tissue Cryopreservation in Children (NCT02646384) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Ovarian Tissue Cryopreservation in Children
United States100 participantsStarted 2017-03-16
Plain-language summary
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.
Who can participate
Age range17 Years
SexFEMALE
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Inclusion criteria
✓. 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
✕
What they're measuring
1
Number of pregnancy and live births after transplantation of cryopreserved ovarian tissue