Infertility
Conditions
Keywords
Fertility preservation, Ovarian Tissue, Cryopreservation, Assisted Reproductive Technology
Brief summary
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.
Interventions
OTHERFrozen ovarian tissue
Use of ovarian tissue cryopreserved and stored at Boston IVF
Sponsors
Boston IVF
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 10 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 10 years | * 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 |
Countries
United States
Outcome results
None listed