Ovarian Tissue Cryopreservation for Fertility Preservation
Primary Purpose
Infertility
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Frozen ovarian tissue
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Fertility preservation, Ovarian Tissue, Cryopreservation, Assisted Reproductive Technology
Eligibility 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
Sites / Locations
- Newton Wellesley Hospital
- Boston IVF
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ovarian tissue cryopreservation
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01682525
Brief Title
Ovarian Tissue Cryopreservation for Fertility Preservation
Official Title
Ovarian Tissue Cryopreservation for Fertility Preservation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston IVF
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Fertility preservation, Ovarian Tissue, Cryopreservation, Assisted Reproductive Technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ovarian tissue cryopreservation
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Frozen ovarian tissue
Intervention Description
Use of ovarian tissue cryopreserved and stored at Boston IVF
Primary Outcome Measure Information:
Title
Safety
Description
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
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Efficacy
Description
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
Time Frame
10 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ryley, MD
Organizational Affiliation
Boston IVF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newton Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Boston IVF
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.bostonivf.com
Description
Related Info
Learn more about this trial
Ovarian Tissue Cryopreservation for Fertility Preservation
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