Ovarian Tissue Cryopreservation in Children

Cancer Clinical Trial

Official title:

Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02646384
• Other study ID #: 14-010037
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 16, 2017
• Est. completion date: January 2026

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Procedure:
• Ovarian tissue cryopreservation
Ovarian tissue will be removed

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pregnancy and live births after transplantation of cryopreserved ovarian tissue		10-20 years

External Links

•   Mayo Clinic Clinical Trials