Ovarian Tissue Cryopreservation (OTC)

January 22, 2026 updated by: Phoenix Children's Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cancer is a health concern; however, science advancement in disease detection and treatment modalities continues to improve patient survival rates. Cancer treatment consequences are gaining importance for survivors, families and providers. Infertility is a primary concern among female cancer survivors as it not only has biological implications, but psychosocial implications as well. Cancer treatment can cause acute ovarian failure, premature menopause and results in reproductive challenges in survivorship. Females who are approaching reproductive age at time of cancer diagnosis, who receive abdominopelvic radiation or high dose alkylating agents and those diagnosed with Hodgkin's lymphoma have increased risk for infertility following treatment. Cancer treatment is not the only treatment that threatens reproductive capacity, but rheumatoid arthritis and lupus treatment may also cause infertility.

Female cancer patients express fertility preservation is extremely important for their long-term psychosocial health. The current American Society for Clinical Oncology Clinical Practice Guideline states that all patients should be made aware of possible side effects of treatment on fertility, and that patients be offered fertility preservation interventions. Embryo banking or egg banking (oocyte preservation) prior to chemotherapy is the most successful options for fertility preservation in women. This option necessitates time for ovarian stimulation and retrieval which can take up to 2-3 weeks and is costly. This option may be longer for those who acquire ovarian hyper-stimulation syndrome and younger patients have a higher risk for OHSS. Embryo banking requires mature oocytes and can cause emotional and physical stress. The financial and physical challenges with fertility preservation motivate the desire to find alternatives for young cancer patients.

Improved freezing and thawing techniques for human oocytes have contributed to pregnancy rates comparable to those using fresh egg following in vitro fertilization. Prior to ovarian tissue cryopreservation there was no fertility preservation intervention available to patients who could not delay treatment or were too young to undergo hormonal stimulation. As of 2017, greater than 130 live births following transplantation of frozen/thawed ovarian tissue have been reported. Ovarian tissue cryopreservation has proven to be a safe and efficient method for preserving future fertility for patients undergoing potentially sterilizing treatments. Ovarian tissue cryopreservation is a standard-of-care in parts of Europe and is routine in several children's hospitals throughout the United States. We propose this option be available to qualifying patients at Phoenix Children's Hospital.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly diagnosed or relapsed malignancy with proposed treatment regimen containing at least ONE (1) of the following:

whole abdomen or pelvic irradiation

total body irradiation

Proposed treatment regimen to include any of the following:

cyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g/m2

any treatment regimen containing procarbazine

bone marrow transplant conditioning regimen containing alkylators

OR health condition or malignancy that requires removal of one or both ovaries. Health status adequate to undergo elective laparoscopic surgery (as per anesthesiologist assessment)

Exclusion Criteria:

  • Pregnancy or a patient who is currently breastfeeding

Patients who are eligible for and agree to oocyte preservation

Anyone deemed high risk for complications from the surgery and/or anesthesia.

Anyone unable to provide consent due to psychiatric conditions or cognitive delay (in parent/guardian for patients <18 years, and patient >18 years)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: girls facing possible infertility

Newly diagnosed female or relapsed malignancy who is 1-25 years of age with proposed treatment regimen containing at least ONE (1) of the following:

whole abdomen or pelvic irradiation total body irradiation

Proposed treatment regimen to include any of the following:

cyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g/m2 any treatment regimen containing procarbazine bone marrow transplant conditioning regimen containing alkylator OR health condition or malignancy that requires removal of one or both ovaries
Procedure: Ovarian tissue removal will be performed laparoscopically
under general anesthesia concomitantly with another scheduled procedure if possible. Following removal, ovarian tissue will be shipped to University of Pittsburg Medical Center, Magee-Womens Research Institute for processing. Freezing and storing techniques will be in accordance with FDA regulations for reproductive tissues, guidelines of the American Association of Tissues Banks and any other applicable federal, state and local regulations. The tissue will be carefully separated dividing the cortex from the medulla. The cortex will then be cryopreserved for long term storage. The medulla will be shipped overnight back to the PCH Department of Pathology for histological evaluation. If pathology finds evidence of cancer in the ovarian tissue provided, they may request that all of the patient's tissue be returned to pathology for a more detailed examination, which may eliminate the tissue available for the patient's future use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who utilize their ovarian tissue and the age at which they use it will be evaluated. The number of patients who elect to have OTC will be analyzed over time to identify trends.
Time Frame: 10 years
data will be investigated via qualitative analysis.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phoenix Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2020

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-195

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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