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Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen: A Study By The National Physicians Cooperative of the Oncofertility Consortium At Northwestern University


Phase 4
18 Years
41 Years
Open (Enrolling)
Female
Malignancy, Fertility

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Trial Information

Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen: A Study By The National Physicians Cooperative of the Oncofertility Consortium At Northwestern University


Women who have not yet undergone this procedure, and who present to the Fertility
Consultants desiring fertility preservation, will be offered participation in the study.

Subjects will undergo an initial visit which will include a blood draw, ultrasound, and any
additional tests or exams that are medically indicated for the subject's diagnosis in
preparation for surgery. Subjects will then undergo an oophorectomy surgery (removal of one
or both ovaries). Following removal, subject's ovarian tissue will be cryopreserved (frozen)
and stored for possible future use. We also plan to collect subjects medical history
information to enter into a research database. Subjects will be followed until they decide
to use their tissue for fertility purposes.

We will also retrospectively enroll women who have already undergone this procedure by
contacting them by mail and offering participation in our ovarian tissue cryopreservation
database.


Inclusion Criteria:



- Woman between the age of 18-41 years who will undergo surgery, chemotherapy, drug
treatment and/or radiation for the treatment or prevention of a medical condition or
malignancy expected to result in permanent and complete loss of subsequent ovarian
function or 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. Those who were not enrolled
at the time of initial diagnosis are eligible if they have not received therapy that
is viewed as likely to result in complete and permanent loss of ovarian function.

- For patients undergoing elective removal of an ovary for fertility preservation only,
have two ovaries.

- Patients who already have stored cryopreserved ovarian tissue in a frozen state prior
to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible
for enrollment with informed consent.

- Signed an approved informed consent and authorization permitting the release of
personal health information. The patient and/or the patient's legally authorized
guardian must acknowledge in writing that consent for specimen collection has been
obtained, in accordance with institutional policies approved by the U.S. Department
of Health and Human Services.

Exclusion Criteria:

- Women with psychological, psychiatric, or other conditions which prevent giving fully
informed consent.

- Women whose underlying medical condition significantly increases their risk of
complications from anesthesia and surgery.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

This study will provide a pool of research ovarian tissue to use to develop and test methods to expand the range of fertility preservation options available to female cancer patients.

Outcome Time Frame:

May 2009 - January 2010

Safety Issue:

No

Principal Investigator

David M Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Sciences University

Authority:

United States: Institutional Review Board

Study ID:

U54RR024347

NCT ID:

NCT00902720

Start Date:

May 2009

Completion Date:

December 2013

Related Keywords:

  • Malignancy
  • Fertility
  • Ovarian
  • Tissue
  • Cryopreservation
  • Neoplasms

Name

Location

Oregon Health and Sciences UniverstiyPortland, Oregon  97239