Recruiting

Ovarian Tissue Freezing

Sponsor:

Phoenix Children's Hospital

Code:

NCT06710769

Conditions

Infertility, Female

Eligibility Criteria

Sex: Female

Age: 1 - 25

Healthy Volunteers: Not accepted

Interventions

Ovarian tissue removal will be performed laparoscopically

Study Details

Brief summary:

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

Conditions

Infertility, Female

Study ID

NCT06710769

Start date

Jul 30, 2020

Status verified date

Jan, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 1 - 25

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Phoenix Childrens

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

More Information

Sponsor

Phoenix Children's Hospital

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Phoenix Children's Hospital on 2026-01-23.