Ovarian Tissue Cryopreservation in Children

NCT02646384 | Active Not Recruiting

• 1 other identifier: 14-010037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Number of pregnancy and live births after transplantation of cryopreserved ovarian tissue

  10-20 years

Study Arms (1)

Ovarian tissue cryopreservation

EXPERIMENTAL

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

Interventions

Ovarian tissue cryopreservation PROCEDURE

Ovarian tissue will be removed

Ovarian tissue cryopreservation

Eligibility Criteria

• Age: Up to 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Female, age birth-17 years
• Meet at least one of the following three conditions:
• 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.
• Or, have a newly diagnosed or recurrent disease affecting fertility.
• For patients undergoing elective removal of all or part of an ovary for fertility preservation only, they must have two ovaries.
• 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.

You may not qualify if:

• Girls with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
• Girls whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
• Subjects with extensive disease whose therapy is deemed palliative by the medical oncologist will not be selected.
• Subjects with suspected severe diminished ovarian reserve, such as a follicle stimulating hormone (FSH) level of \> 15.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 33910089 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasms

Study Officials

• Zaraq Khan, M.B.B.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 5, 2016
• Study Start: March 16, 2017
• Primary Completion (Estimated): January 22, 2040
• Study Completion (Estimated): January 22, 2040
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)