Ovarian Tissue Cryopreservation for Fertility Preservation

NCT01682525 | Withdrawn

• 1 other identifier: N09-454
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility

Keywords

Fertility preservation; Ovarian Tissue; Cryopreservation; Assisted Reproductive Technology

Outcome Measures

Primary Outcomes (1)

• 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

  10 years

Secondary Outcomes (1)

• Efficacy

  10 years

Study Arms (1)

Ovarian tissue cryopreservation

EXPERIMENTAL

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

Interventions

Frozen ovarian tissue OTHER

Use of ovarian tissue cryopreserved and stored at Boston IVF

Ovarian tissue cryopreservation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston IVF: lead

Study Sites (2)

Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• David Ryley, MD

  Boston IVF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reproductive Endocrinologist

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 11, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)