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Ovarian Tissue Cryopreservation for Fertility Preservation

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.
 
ClinicalTrials.gov Identifier: NCT01682525
Recruitment Status : Withdrawn
First Posted : September 11, 2012
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
David Ryley, MD, Boston IVF

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 11, 2012
Last Update Posted Date February 4, 2016
Study Start Date  ICMJE May 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01682525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ovarian Tissue Cryopreservation for Fertility Preservation
Official Title  ICMJE Ovarian Tissue Cryopreservation for Fertility Preservation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE Other: Frozen ovarian tissue
Use of ovarian tissue cryopreserved and stored at Boston IVF
Study Arms  ICMJE 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.
Intervention: Other: Frozen ovarian tissue
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 13, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2012)
100
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01682525
Other Study ID Numbers  ICMJE N09-454
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Ryley, MD, Boston IVF
Study Sponsor  ICMJE Boston IVF
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Ryley, MD Boston IVF
PRS Account Boston IVF
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP