Ovarian Tissue Cryopreservation for Fertility Preservation

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Infertility	Other: Frozen ovarian tissue	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Ovarian Tissue Cryopreservation for Fertility Preservation
Study Start Date :	May 2012
Actual Primary Completion Date :	March 2015
Actual Study Completion Date :	March 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 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.	Other: Frozen ovarian tissue; Use of ovarian tissue cryopreserved and stored at Boston IVF

Outcome Measures

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Primary Outcome Measures :

1. Safety [ Time Frame: 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 :

1. Efficacy [ Time Frame: 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
Newton Wellesley Hospital
Newton, Massachusetts, United States, 02462
Boston IVF
Waltham, Massachusetts, United States, 02451

Sponsors and Collaborators

Boston IVF

Investigators

Principal Investigator:	David Ryley, MD	Boston IVF

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Responsible Party:	David Ryley, MD, Reproductive Endocrinologist, Boston IVF
ClinicalTrials.gov Identifier:	NCT01682525 History of Changes
Other Study ID Numbers:	N09-454
First Posted:	September 11, 2012
Last Update Posted:	February 4, 2016
Last Verified:	February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by David Ryley, MD, Boston IVF:

Fertility preservation; Ovarian Tissue; Cryopreservation; Assisted Reproductive Technology

Additional relevant MeSH terms:

Infertility; Genital Diseases, Male; Genital Diseases, Female