Ovarian Tissue Cryopreservation for Fertility Preservation
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ClinicalTrials.gov Identifier: NCT01682525 |
Recruitment Status
:
Withdrawn
First Posted
: September 11, 2012
Last Update Posted
: February 4, 2016
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Infertility | Other: Frozen ovarian tissue | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Ovarian Tissue Cryopreservation for Fertility Preservation |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |
Arm | Intervention/treatment |
---|---|
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.
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Other: Frozen ovarian tissue
Use of ovarian tissue cryopreserved and stored at Boston IVF
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- 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
- 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

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
United States, Massachusetts | |
Newton Wellesley Hospital | |
Newton, Massachusetts, United States, 02462 | |
Boston IVF | |
Waltham, Massachusetts, United States, 02451 |
Principal Investigator: | David Ryley, MD | Boston IVF |
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 Posted: | September 11, 2012 Key Record Dates |
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 |