NCT00902720 — Ovarian Tissue Freezing For Fertility Preservation · CancerIndex
Clinical trial · Interventional
Ovarian Tissue Freezing For Fertility Preservation
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
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
The ovarian tissue is frozen and banked at the in vitro fertilization lab at the Center for Health and Healing at OHSU.
interventionNames
Other: Tissue sample storage
Primary outcomes (1)
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 (5)
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
Eligibility
Eligibility (as posted)
Sex
Female
Minimum age
18 Years
Maximum age
41 Years
Show eligibility criteria text
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.
References
Publications (78)
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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.
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