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

NCT02678910 | Completed

• 1 other identifier: 15-0927-F1V
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Hematologic Disorder; Rheumatologic Disorder; Infertility

Outcome Measures

Primary Outcomes (1)

• Number of subjects who elect to have ovarian tissue cryopreservation in one year.

  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.

  1 year from IRB protocol approval and study open date

Secondary Outcomes (1)

• Number of subjects who elect to have ovarian tissue cryopreservation over a 5 year prior period of time.

  5 years from IRB protocol approval and study open date

Study Arms (1)

Ovarian Cryopreservation

EXPERIMENTAL

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

Interventions

Ovarian Cryopreservation PROCEDURE

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.

Ovarian Cryopreservation

Eligibility Criteria

• Age: 12 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vlad Radulescu: lead

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Norton Health Care

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Diseases; Collagen Diseases; Infertility

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Lars Wagner, MD

  University of Kentucky

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: February 10, 2016
• Study Start: February 1, 2017
• Primary Completion: June 21, 2017
• Study Completion: June 21, 2017
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)