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Ovarian Tissue Cryopreservation for Fertility Preservation


N/A
18 Years
40 Years
Open (Enrolling)
Female
Infertility

Thank you

Trial Information

Ovarian Tissue Cryopreservation for Fertility Preservation


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

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

Outcome Time Frame:

10 years

Safety Issue:

Yes

Principal Investigator

David Ryley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston IVF

Authority:

United States: Institutional Review Board

Study ID:

N09-454

NCT ID:

NCT01682525

Start Date:

May 2012

Completion Date:

Related Keywords:

  • Infertility
  • Fertility preservation
  • Ovarian Tissue
  • Cryopreservation
  • Assisted Reproductive Technology
  • Infertility

Name

Location
Newton Wellesley Hospital Newton, Massachusetts  02462
Boston IVF Waltham, Massachusetts  02451