NCT02646384Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Jan 2016
- Start date
- 16 Mar 2017
- Primary completion date
- 22 Jan 2040
- Lead sponsor
- Mayo Clinic
- Diseases
- Childhood cancers
- NCT number
- NCT02646384
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 16 Mar 2017 to the primary completion date, 22 Jan 2040
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Subjects with suspected severe diminished ovarian reserve, such as a follicle stimulating hormone (FSH) level of \> 15.
Who the study is looking for
- 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.
Age in the registry: - to 17 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.