Ovarian Tissue Cryopreservation for Fertility Preservation

Infertility Clinical Trial

Official title:

Ovarian Tissue Cryopreservation for Fertility Preservation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01682525
• Other study ID #: N09-454
• Status: Withdrawn
• Phase: N/A
• First received: September 4, 2012
• Last updated: February 3, 2016
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: Boston IVF
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Frozen ovarian tissue
Use of ovarian tissue cryopreserved and stored at Boston IVF

Locations

Country	Name	City	State
United States	Newton Wellesley Hospital	Newton	Massachusetts
United States	Boston IVF	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston IVF

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 years	Yes
Secondary	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	10 years	No

External Links

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