Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2017-03-16
2040-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ovarian tissue cryopreservation
Children faced with a fertility threatening diagnosis or treatment plan will be offered ovarian tissue cryopreservation, particularly if pre menarchal and without other options to preserve fertility. Although considered experimental, there are over 120 live births worldwide using this technique
Ovarian tissue cryopreservation
Ovarian tissue will be removed
Interventions
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Ovarian tissue cryopreservation
Ovarian tissue will be removed
Eligibility Criteria
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Inclusion Criteria
2. Meet at least one of the following three conditions:
1. 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.
2. 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.
3. Or, have a newly diagnosed or recurrent disease affecting fertility.
3. For patients undergoing elective removal of all or part of an ovary for fertility preservation only, they must have two ovaries.
4. 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
2. Girls whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
3. Subjects with extensive disease whose therapy is deemed palliative by the medical oncologist will not be selected.
4. Subjects with suspected severe diminished ovarian reserve, such as a follicle stimulating hormone (FSH) level of \> 15.
17 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Zaraq Khan, M.B.B.S.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Joshi VB, Behl S, Pittock ST, Arndt CAS, Zhao Y, Khan Z, Granberg CF, Chattha A. Establishment of a Pediatric Ovarian and Testicular Cryopreservation Program for Malignant and Non-Malignant Conditions: The Mayo Clinic Experience. J Pediatr Adolesc Gynecol. 2021 Oct;34(5):673-680. doi: 10.1016/j.jpag.2021.04.006. Epub 2021 Apr 25.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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14-010037
Identifier Type: -
Identifier Source: org_study_id