Cancer Clinical Trial
— PTOOfficial title:
Fertility Preservation With Ovarian Tissue Freezing
The purpose of this study is to obtain ovarian tissue from female patients undergoing
gonadotoxic treatments or gonadal ablating surgery, and that in consequence may see their
future fertility impaired. Participants will be offered to preserve (freeze) and use ovarian
tissue for the purpose of conceiving in the future.
Although, 86 live births have been reported with ovarian tissue cryo-preservation and
grafting, the procedure is still considered experimental.
This research, will help us to learn and validate how to perform ovarian tissue
cryo-preservation and thawing in the fertility preservation context.
Status | Not yet recruiting |
Enrollment | 250 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 2 Months to 18 Years |
Eligibility |
Inclusion Criteria: 1. Females, > 2 month and < 18 years of age 2. Undergo 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. 3. Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries. 4. Subject may have newly diagnosed or recurrent disease. 5. Subject who already has stored cryopreserved ovarian tissue in a frozen state prior to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible for enrolment with informed consent. 6. Subject not eligible to standard fertility preservation 7. The subject and/or the subject's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies. Exclusion Criteria: 1. Women with psychological, psychiatric or other conditions which prevent giving fully informed consent. 2. Women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery. 3. Women to whom the research intervention may decrease the survival or the treatment response to the underlying disease. 4. AMH (Anti Müllerian Hormone) <0.016 ng/dl 5. Women whose surgery is preformed outside the CHU Ste-Justine 6. Patients eligible to a standard fertility preservation procedure. |
Country | Name | City | State |
---|---|---|---|
Canada | CHU Ste-Justine | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cryopreservation of ovarian tissu by vitrification | Measure the fertility rate of cryopreservation and grafting by ovarian tissue vitrification. | 5 years |
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