Ovarian Tissue Cryopreservation in Children

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02646384
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 105.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Procedure: Ovarian tissue cryopreservation	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen
• Actual Study Start Date: Mar 16, 2017
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Procedure: Ovarian tissue cryopreservation; Ovarian tissue will be removed

Outcome Measures

Primary Outcome Measures

1. Number of pregnancy and live births after transplantation of cryopreserved ovarian tissue [10-20 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: Female
• Accepts 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:

3. 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.

4. 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.

5. Or, have a newly diagnosed or recurrent disease affecting fertility.

6. For patients undergoing elective removal of all or part of an ovary for fertility preservation only, they must have two ovaries.

7. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Zaraq Khan, M.B.B.S., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Zaraq Khan, PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02646384
• Other Study ID Numbers: 14-010037
• First Posted: Jan 5, 2016
• Last Update Posted: Feb 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 2, 2022