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Ovarian Tissue Cryopreservation for Fertility Preservation

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682525
First Posted: September 11, 2012
Last Update Posted: February 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Ryley, MD, Boston IVF
  Purpose

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 Intervention
Infertility Other: Frozen ovarian tissue

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ovarian Tissue Cryopreservation for Fertility Preservation

Further study details as provided by David Ryley, MD, Boston IVF:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 0
Study Start Date: May 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682525


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

Additional Information:
Responsible Party: David Ryley, MD, Reproductive Endocrinologist, Boston IVF
ClinicalTrials.gov Identifier: NCT01682525     History of Changes
Other Study ID Numbers: N09-454
First Submitted: September 4, 2012
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