Ovarian Tissue Cryopreservation for Fertility Preservation

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Boston IVF
Sponsor:
Information provided by (Responsible Party):
David Ryley, MD, Boston IVF
ClinicalTrials.gov Identifier:
NCT01682525
First received: September 4, 2012
Last updated: January 28, 2014
Last verified: January 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ovarian Tissue Cryopreservation for Fertility Preservation

Resource links provided by NLM:


Further study details as provided by Boston IVF:

Primary Outcome Measures:
  • Safety [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Primary Completion Date: May 2022 (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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682525

Contacts
Contact: David Ryley, MD 617-735-9000 dryley@bostonivf.com
Contact: Stephanie Morris, MD 617-243-5205 SNMORRIS@PARTNERS.ORG

Locations
United States, Massachusetts
Newton Wellesley Hospital Recruiting
Newton, Massachusetts, United States, 02462
Contact: Stephanie Morris, MD    617-243-5205    SNMORRIS@PARTNERS.ORG   
Sub-Investigator: Stephanie Morris, MD         
Boston IVF Recruiting
Waltham, Massachusetts, United States, 02451
Contact: David Ryley, MD    617-735-9000    dryley@bostonivf.com   
Principal Investigator: David Ryley, MD         
Sponsors and Collaborators
Boston IVF
Investigators
Principal Investigator: David Ryley, MD Boston IVF
  More Information

Additional Information:
No publications provided

Responsible Party: David Ryley, MD, Reproductive Endocrinologist, Boston IVF
ClinicalTrials.gov Identifier: NCT01682525     History of Changes
Other Study ID Numbers: N09-454
Study First Received: September 4, 2012
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston IVF:
Fertility preservation
Ovarian Tissue
Cryopreservation
Assisted Reproductive Technology

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014