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Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis/Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678910
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Vlad Radulescu, University of Kentucky

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 41 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergo standard of care 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.
  • 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.
  • Participant undergoing elective removal of an ovary for fertility preservation only must have two ovaries.
  • Participant who already has 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.
  • Is not a candidate for or chooses not to utilize embryo or oocyte banking.

Exclusion Criteria:

  • Psychological, psychiatric or other conditions which prevent giving fully informed consent.
  • Underlying medical condition which significantly increases risk of complications from anesthesia and surgery.
  • Participants with a large cancerous mass in the ovary that is being removed; cryopreservation will not be performed on portions of the ovary.
  • Blood testing indicates that the participant does not have enough eggs remaining in her ovary.

Information from the National Library of Medicine

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


Contacts
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Contact: Charity Rogers, RN (859) 257-2321 Charity.Rogers@uky.edu
Contact: Lars Wagner, MD (859) 218-0931 Lars.Wagner@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Charity Rogers, RN    859-257-2321    charity.rogers@uky.edu   
Contact: Lars Wagner, MD    (859) 323-5321    lars.wagner@uky.edu   
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         
Sponsors and Collaborators
Vlad Radulescu
Investigators
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Study Director: Lars Wagner, MD University of Kentucky
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Responsible Party: Vlad Radulescu, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02678910    
Other Study ID Numbers: 15-0927-F1V
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD excluding personal identifiers will be shared with the collaborators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rheumatic Diseases
Infertility
Hematologic Diseases
Collagen Diseases
Disease
Pathologic Processes
Connective Tissue Diseases
Musculoskeletal Diseases