Ovarian Tissue Cryopreservation in Females Undergoing Procedures That Will Potentially Lead To Loss of Ovarian Function

NCT ID: NCT01993732

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-06
• Study Completion Date: 2018-06-28

Brief Summary

The purpose of this study is to retrieve and cryopreserve ovarian tissue from females undergoing a treatment that may lead to irreversible loss of ovarian function.

Detailed Description

The aim of this preliminary study is to retrieve and properly cryopreserve ovarian tissue for autotransplantation in any premenopausal female whose ovarian function is threatened in a physiological, pathological or iatrogenic manner in an effort to observe the return of ovarian endocrine function and development of egg(s) appropriate for use in in vitro fertilization.

Conditions

Cancer; Effects of Chemotherapy; Unspecified Complication of Bone Marrow Transplant; Auto Immune Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Retrieval and Cryopreservation

Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.

Group Type: EXPERIMENTAL

Retrieval and Cryopreservation

Intervention Type: PROCEDURE

Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.

Interventions

Retrieval and Cryopreservation

Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient must be female.
• Patient must have a disease process where the disease or its treatment adversely affects ovarian function.
• Patient must be recommended for this study by their oncologist or specialist.
• Patient (or legally authorized representative) must sign an informed consent.

Exclusion Criteria

• Patients cannot be male.
• Patients must not be HIV positive.
• Patient cannot have a poor diagnosis such that she is not expected to survive to adulthood.
• Patient cannot have any medical condition that would contraindicate surgery.
• Patient cannot have any medical condition that would contraindicate general anesthesia.
• Patient cannot have any medical condition that would contraindicate pregnancy.

• Minimum Eligible Age: 3 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Estil Strawn

Professor, Director of Division of Reproductive Endocrinology and Infertility

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Estil Strawn, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

126204

Identifier Type: -

Identifier Source: org_study_id