Ovarian Tissue Cryopreservation in Post Pubertal (OTC-Post Pubertal)

Recruiting

• Conditions: Pediatric Cancer

• Registration Number: NCT05309746
• Lead Sponsor: Erin Rowell

Brief Summary

The purpose of this study is to safely remove ovarian tissue in pediatric patients, who are at risk for infertility from their medical treatment, for freezing for future restoration of fertility and hormone function.

Detailed Description

Participants are invited to take part in this study because they will be treated with chemotherapy, radiation and/or surgery that will likely affect the child's ovaries and cause the child to become infertile (unable to become pregnant) in the future.

The ovaries are reproductive glands found only in females. These glands are located in the pelvis (hip area). The ovaries produce eggs and female hormones. During each monthly menstrual cycle, an egg is released from one ovary. This study seeks to find out if removing an ovary in adolescents and children who have reached puberty, and who are about to undergo chemotherapy and/or radiation may preserve, or keep, their ability to have children in the future. The optional ovarian tissue that is removed for research will also be used to study better ways to store the ovarian tissue and to improve of the tissue in the future.

This study has two parts: the removal of the ovarian tissue, and the storage of the ovarian tissue. A process called Ovarian Tissue Cryopreservation will be used to store the removed ovarian tissue. This kind of freezing is a special method that is used to try to prevent the eggs from being damaged, and to keep them frozen for a long time. The frozen tissue will be available to the child to be used at a later time.

As a part of the study the investigator is asking participants to donate a 3-4mm biopsy (less than 10% of the ovary) of their ovarian tissue to future research before it is stored for their own use. The investigator also enrolls patients in a database study for yearly survey evaluation for long term outcome of ovarian tissue removal and potential restoration.

Ovarian Tissue Cryopreservation involves a surgical procedure where ovarian tissue of post pubertal patients is surgically removed and frozen, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline. Participation in the study is voluntary.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2030-12
• Study Completion: 2035-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• Post-pubertal individuals < 30 years of age

• Will undergo imminent surgery, chemotherapy or radiation therapy that has implications on future fertility and reproductive hormone potential: any health condition or malignancy that requires removal of all or part of one or both ovaries, whole abdomen or pelvic irradiation≥ 10Gy in post-pubertal girls or ≥15 Gy in pre- pubertal girls

• total body irradiation, and

• alkylating-intensive chemotherapy

  • cyclophosphamide cumulative dose ≥7.5 g/m2

  • any treatment regimen containing procarbazine

  • busulfan cumulative dose >600 mg/m2

  • alkylating chemotherapy conditioning prior to stem cell transplantation

    • combination of any alkylating agent with total body irradiation or whole abdomen or pelvic radiation
    • cranial radiation ≥30 Gy
    • summed alkylating agent dose score ≥3 (Green et al., 2009)
    • cyclophosphamide equivalent dose (CED) ≥ 4,000 mg/m2 (Green et al., 2014)

• Patients may have newly diagnosed or relapsed disease. Those who were not enrolled at diagnosis are eligible even if they have received therapy that is viewed as likely to result in complete and permanent loss of ovarian function. However, these patients will be required to provide a 4mm punch biopsy of their tissue for research.

Exclusion Criteria

• Patients with no anticipated oncologic therapies
• Pregnant children
• Children with one ovary
• Children deemed high risk for perioperative complications
• Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ovarian Tissue Freezing for Fertility Preservation in Post-Pubertal Children Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen	3 months	Most of surgically removed tissue will be stored for the child's future use. Participants have the option of donating for research purposes a small piece of the ovarian tissue, a small amount of the child's blood and the media used to process the ovarian tissue (which is otherwise discarded, for research which evaluates optimizing ovarian cryopreservation and fertility restoration techniques.

Secondary Outcome Measures

Name	Time	Method
Annual survey follow-up for participants who undergo ovarian tissue cryopreservation	yearly for up to 20 years	The research study coordinator will contact families by email or telephone once per year and ask a series of questions related to ovarian function, such as frequency of menstruation.

Trial Locations

Locations (1)

Ann &Robert H Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States