Cancer
Conditions
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.
Interventions
PROCEDUREOvarian tissue cryopreservation
Ovarian tissue will be removed
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of pregnancy and live births after transplantation of cryopreserved ovarian tissue | 10-20 years |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZaraq Khan, M.B.B.S.
Mayo Clinic
Outcome results
None listed