Ovarian Tissue Cryopreservation for Fertility Preservation

Study Overview
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Brief Summary
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To provide a novel fertility preservation option for patients facing a fertility threatening cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation program. To determine if ovarian tissue cryopreservation provides women with a useful, successful option for fertility preservation The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an alternative option for fertility preservation.

Official Title
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Ovarian Tissue Cryopreservation for Fertility Preservation

Conditions
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Infertility

Intervention / Treatment
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* Other: Frozen ovarian tissue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy which are likely to result in permanent loss of subsequent ovarian function or diminished fertility Have a medical condition or malignancy that requires removal of all or part of one or both ovaries Patients may have newly diagnosed or recurrent disease Be in good health so as to be able to undergo laparoscopic surgery as determined by history and physical examinations, and consultation with the medical oncologist, reproductive endocrinologist, surgeon and anesthesiologist Exclusion Criteria: Moderate to high-risk of ovarian failure due to treatment Documented ovarian metastasis HIV or hepatitis (B, C)-positive serology Absolute surgical contraindications ECOG performance status of 0 or 1 Pregnancy Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ovarian tissue cryopreservation<br>The ovarian tissue is cryopreserved and stored at Boston IVF, which is an FDA compliant and American Association of Tissue Banks accredited long term storage facility for reproductive tissue. | Other: Frozen ovarian tissue<br>* Use of ovarian tissue cryopreserved and stored at Boston IVF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety, which will be assessed by tracking the number of minor and major complications of the procedure including the following: Minor: Local infection Major: Blood loss requiring blood transfusion, major infection requiring admission or parental antibiotics, injury to surrounding organs requiring further procedures, hospitalization due to unforeseen operative complication | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Proportion of women who attempt pregnancy Proportion of women who become pregnant and outcome Proportion of women using assisted reproduction after re-implantation or ovarian tissue. Menstrual cyclicity and ovarian reserve in those with and without re-implantation | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fertility preservation, Ovarian Tissue, Cryopreservation, Assisted Reproductive Technology