Ovarian Tissue Cryopreservation for Fertility Preservation

Boston IVF

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Infertility

Interventions

Frozen ovarian tissueOTHER

Use of ovarian tissue cryopreserved and stored at Boston IVF

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (2)

Newton Wellesley Hospital

Newton, Massachusetts, United States

Boston IVF

Waltham, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 10 years

Secondary Outcomes

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

Time frame: 10 years

Data from ClinicalTrials.gov

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