Preservation of Ovarian Tissue and Chemo-Radiotherapy

Completed · Not applicable

Conditions studied: Endocrine Disorders of Female Reproductive System, Secondary Infertility, Infertility Involuntary

In brief

The purpose of this study is to assess the results of ovarian tissue freezing, such as resumption or initiation of menses (menstruation: the discharge of blood and tissue from the uterus that happens about every 4 weeks in females who are not pregnant) and pregnancy, prior to starting chemotherapy or radiation treatment (commonly used for cancer treatment or for other conditions such as multiple sclerosis, psoriasis, rheumatoid arthritis). Females who are about to undergo chemotherapy or radiation therapy for cancer or these other medical conditions may stop having menses and may not be able to produce a biological child. Girls who have not achieved puberty and are exposed to chemotherapy (alkylating agents) or radiation treatment, the risk is up to 22-50%. In contrast, girls older than 10 years, or who have achieved puberty, experience acute ovarian failure in over 50% of the cases. By freezing and preserving ovarian tissue will help prevent these outcomes. In fact, when you are considered cured of your disease, you will have another surgical procedure where your own ovarian tissue will be transplanted back to you. This surgery will increase the possibility of resuming/initiating menses and the chance to have a pregnancy.

Key facts

Study ID

NCT02429349

Run by

University of Tennessee

People needed

2

Starts

2015-05-01

Expected to finish

2020-06-30

Last updated by the study team

2020-11-13

Who can join

Age: 8 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pre- and post-pubertal patients who are diagnosed with conditions that necessitate chemo- or radiotherapy and wish to preserve their ovarian function.

You may not qualify if…

• Patients with acute or chronic conditions that would preclude surgery. These include, but are not limited to, hyper- or hypo-coagulation disorders, lung conditions precluding mechanical ventilation, brain death.
• Patients for whom the primary oncologist and/or pathologist discourage entering the protocol because of specific condition characteristics. These include, but are not limited to, cancers with high risk of ovarian metastasis such as leukemia and non-Hodgkin lymphoma.
• Patients with known positive bone marrow for leukemia or solid tumor.
• Patients whose tumor is in an organ that communicates with the peritoneum and peritoneal sampling at time of primary excision shows evidence of disease.
• Patients older than 40 years of age.
• Males.

Where it is running

• Methodist/LeBonheur Hospital — Germantown, Tennessee, United States
• LeBonheur Children's Hospital — Memphis, Tennessee, United States
• Regional One Health Ob-Gyn Clinic — Memphis, Tennessee, United States
• Regional One Health, Regional Medical Center, Operating Room — Memphis, Tennessee, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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