Clinical trial NCT02646384: Ovarian Tissue Cryopreservation in Children
Official title: Ovarian Tissue Freezing for Fertility Preservation in Girls Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 100
Sex: FEMALE
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: (All inclusion criteria must be met.)

1. Female, age birth-17 years
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: (Any exclusion criteria will disqualify.)

1. Girls with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
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.

Primary outcomes:
measure: Number of pregnancy and live births after transplantation of cryopreserved ovarian tissue
timeFrame: 10-20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Zaraq Khan, M.B.B.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.