Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis/Treatment
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|ClinicalTrials.gov Identifier: NCT02678910|
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : March 15, 2019
The purpose of this research is to obtain ovarian tissue from female participants who will receive therapy which is expected to result in a loss or impairment of ovarian function and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of initiating a pregnancy in the future.
Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue will be used for the participant's future use. There have been 86 pregnancies as a result of frozen ovarian tissue that has been re-implanted back into the pelvis and hormonal function has been restored in individuals for up to 7 years.
By doing this study, the investigators hope to learn of how to successfully freeze and thaw ovarian tissue in a manner that permits subsequent use by patients at some point in the future. Participation may also advance our knowledge of how to successfully mature follicles and oocytes (eggs) that are contained in these tissues which may help others in the future.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Hematologic Disorder Rheumatologic Disorder Infertility||Procedure: Ovarian Cryopreservation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Ovarian Cryopreservation
Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue will be used for the participant's future use.
Procedure: Ovarian Cryopreservation
The ovarian tissue will be removed at a UK Healthcare facility and evaluated for gross disease by a pathologist, embryologist, andrologist or REI physician. The ovarian cortex will be dissected from the medulla and cut into strips in culture/holding media, washed to remove blood cells, and cryopreserved. Cryopreservation will be performed using modifications of the techniques described by Gosden et al. (1994) or will be vitrified using a modification of the techniques of Kuwayama et al., 2007.
- Number of subjects who elect to have ovarian tissue cryopreservation in one year. [ Time Frame: 1 year from IRB protocol approval and study open date ]The investigator will describe the number of subjects who elect ovarian tissue cryopreservation (OTC) over a 1 year period of time to determine feasibility of OTC in oncology subjects receiving chemotherapy and radiation.
- Number of subjects who elect to have ovarian tissue cryopreservation over a 5 year prior period of time. [ Time Frame: 5 years from IRB protocol approval and study open date ]The investigator will describe the number of subjects who elect ovarian tissue cryopreservation (OTC) over a 5 year period of time to determine feasibility of OTC in oncology subjects receiving chemotherapy and radiation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678910
|Contact: Charity Rogers, RN||(859) 257-2321||Charity.Rogers@uky.edu|
|Contact: Lars Wagner, MD||(859) 218-0931||Lars.Wagner@uky.edu|
|United States, Kentucky|
|University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Contact: Charity Rogers, RN 859-257-2321 firstname.lastname@example.org|
|Contact: Lars Wagner, MD (859) 323-5321 email@example.com|
|Principal Investigator: Lars Wagner, MD|
|Norton Health Care||Not yet recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Leslie A. Appiah, MD 859-323-5410 Leslie.Appiah@uky.edu|
|Principal Investigator: Leslie A. Appiah, MD|
|Study Director:||Lars Wagner, MD||University of Kentucky|