Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis/Treatment

Completed · Not applicable

Conditions studied: Cancer, Hematologic Disorder, Rheumatologic Disorder, Infertility

In brief

The purpose of this research is to obtain ovarian tissue from female participants who will receive therapy which is expected to result in a loss or impairment of ovarian function and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of initiating a pregnancy in the future. Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue will be used for the participant's future use. There have been 86 pregnancies as a result of frozen ovarian tissue that has been re-implanted back into the pelvis and hormonal function has been restored in individuals for up to 7 years. By doing this study, the investigators hope to learn of how to successfully freeze and thaw ovarian tissue in a manner that permits subsequent use by patients at some point in the future. Participation may also advance our knowledge of how to successfully mature follicles and oocytes (eggs) that are contained in these tissues which may help others in the future.

Key facts

Study ID

NCT02678910

Run by

Vlad Radulescu

People needed

2

Starts

2017-02-01

Expected to finish

2017-06-21

Last updated by the study team

2020-12-09

Who can join

Age: 12 and older, up to 41. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Undergo standard of care surgery, chemotherapy, drug treatment, and/or radiation for the treatment or prevention of a medical condition or malignancy expected to result in permanent and complete loss of subsequent ovarian function.
• Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
• May have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis are eligible if they have not received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
• Participant undergoing elective removal of an ovary for fertility preservation only must have two ovaries.
• Participant who already has stored cryopreserved ovarian tissue in a frozen state prior to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible for enrollment with informed consent.
• Is not a candidate for or chooses not to utilize embryo or oocyte banking.

You may not qualify if…

• Psychological, psychiatric or other conditions which prevent giving fully informed consent.
• Underlying medical condition which significantly increases risk of complications from anesthesia and surgery.
• Participants with a large cancerous mass in the ovary that is being removed; cryopreservation will not be performed on portions of the ovary.
• Blood testing indicates that the participant does not have enough eggs remaining in her ovary.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• Norton Health Care — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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