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Ovarian Tissue Cryopreservation for Fertility Preservation
This study has been withdrawn prior to enrollment.
Sponsor:
Boston IVF
Information provided by (Responsible Party):
David Ryley, MD, Boston IVF
ClinicalTrials.gov Identifier:
NCT01682525
First received: September 4, 2012
Last updated: February 3, 2016
Last verified: February 2016
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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| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01682525
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | September 4, 2012 |
| Last Updated: | February 3, 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 |
ClinicalTrials.gov processed this record on August 17, 2017