Ovarian Tissue Cryopreservation for Fertility Preservation

This study has been withdrawn prior to enrollment.

Sponsor:

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

History of Changes

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


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)
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

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:

Related Info This link exits the ClinicalTrials.gov site


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
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by 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 September 30, 2016

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