Ovarian Tissue Cryopreservation for Fertility Preservation

Boston IVF

Status: Withdrawn

Conditions: Infertility

Treatments: Other: Frozen ovarian tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT01682525

N09-454

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Ovarian tissue cryopreservation

Experimental group

Description:

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.

Treatment:

Other: Frozen ovarian tissue