Clinical trial NCT00902720: Ovarian Tissue Freezing For Fertility Preservation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malignancy
Fertility
Keywords: Ovarian
Tissue
Cryopreservation
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-05-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to offer an alternative method to women who wish to preserve the possibility of fertility, as well as to learn more about the ability of human eggs to survive and function after long term storage in frozen ovaries (ovarian tissue cryopreservation). The study will seek to preserve ovarian tissue and reproductive potential for patients whose medical or surgical treatment may harm ovaries or remove ovarian tissue.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: May 2009 - January 2010
Secondary outcomes:
measure: Optimize techniques for freezing and thawing of ovarian tissue for use in transplant or in vitro follicle maturation (IFM).
timeFrame: May 2009 - January 2010
measure: Investigate factors affecting successful maturation of immature follicles obtained from ovarian tissue including the use of 3-dimensional biogel scaffolds, growth factors, hormones and other culture conditions.
timeFrame: May 2009 - January 2010
measure: Determine the efficacy of ovarian cryopreservation techniques.
timeFrame: May 2009 - January 2010
measure: Provide long term follow up on patients who have ovarian tissue frozen for their own use.
timeFrame: May 2009 - January 2010
measure: A substantial portion of the patient's tissue will be cryopreserved and reserved for her own use.
timeFrame: May 2009 - January 2010
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Sciences Universtiy
state: Oregon
Study officials:
affiliation: Oregon Health and Sciences University
name: David M Lee, MD
role: PRINCIPAL_INVESTIGATOR
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