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Recruiting

NCT Number: NCT06710769

Ovarian Tissue Cryopreservation

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

Recruiting

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Key information

Age range

1 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ovarian tissue removal will be performed laparoscopically

Procedure

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Walsh, MD

CONTACT

[email protected]

602-933-4483

Briana Fodor

CONTACT

[email protected]

602-933-4483

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Official study title

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

Acronym: OTC

Important dates

Study start
2020
Primary completion
2030
Study completion
2031
First posted
Nov 29, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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