Status:
SUSPENDED
Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women
Lead Sponsor:
Baylor College of Medicine
Conditions:
Fertility Preservation
Eligibility:
FEMALE
Up to 42 years
Phase:
NA
Brief Summary
This study will compare efficacy of ovarian tissue freezing using slow-freeze versus vitrification methods.
Detailed Description
The primary objective of this study is to determine the efficacy of ovarian tissue cryopreservation using slow-freeze and vitrification methods in enabling long-term preservation of ovarian function a...
Eligibility Criteria
Inclusion
- Female Patients only
- 0-42 years of age.
- Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy that places the patient at risk for impaired ovarian function and infertility 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 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.
- Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian(s) must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
Exclusion
- Girls and women with psychological, psychiatric, or other conditions which prevent giving informed consent.
- Girls and women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
- Girls and women who are permanently menopausal, as documented by history and FSH levels.
- Girls and women who are pregnant.
Key Trial Info
Start Date :
August 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05434936
Start Date
August 11 2017
End Date
October 10 2027
Last Update
June 18 2023
Active Locations (1)
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1
Texas Children's Hospital Pavilion For Women
Houston, Texas, United States, 77030