Ovarian Tissue Cryopreservation for Fertility Preservation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-03-31

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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ovarian tissue cryopreservation

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.

Group Type EXPERIMENTAL

Frozen ovarian tissue

Intervention Type OTHER

Use of ovarian tissue cryopreserved and stored at Boston IVF

Interventions

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Frozen ovarian tissue

Use of ovarian tissue cryopreserved and stored at Boston IVF

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No