Ovarian Tissue Freezing For Fertility Preservation
Status: | Recruiting |
---|---|
Conditions: | Cancer, Women's Studies |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - 41 |
Updated: | 3/21/2019 |
Start Date: | May 2009 |
End Date: | December 2019 |
Contact: | David M Lee, MD |
Email: | leedavi@ohsu.edu |
Phone: | 503-418-3700 |
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.
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.
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.
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.
We found this trial at
1
site
Portland, Oregon 97239
Principal Investigator: David M Lee, MD
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