Ovarian Tissue Cryopreservation for Fertility Preservation

Not Applicable

Withdrawn

• Conditions: Infertility
• Interventions: Other: Frozen ovarian tissue

• Registration Number: NCT01682525
• Lead Sponsor: Boston IVF

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ovarian tissue cryopreservation	Frozen ovarian tissue	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Newton Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States

Boston IVF; 🇺🇸 Waltham, Massachusetts, United States