Ovarian Tissue Cryopreservation in Children

Mayo Clinic

Status: Active, not recruiting

Conditions: Cancer

Treatments: Procedure: Ovarian tissue cryopreservation

Study type: Interventional

Funder types: Other

Identifiers

NCT02646384

14-010037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Ovarian tissue cryopreservation

Experimental group

Description:

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

Treatment:

Procedure: Ovarian tissue cryopreservation