Ovarian Tissue Cryopreservation for Fertility Preservation
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2014 by Boston IVF
Sponsor:
Boston IVF
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
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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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ovarian Tissue Cryopreservation for Fertility Preservation |
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
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 |
ClinicalTrials.gov processed this record on March 03, 2015