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

NCT01993732 | Completed

• 1 other identifier: 126204
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Cancer; Cryopreservation; Ovarian Function; In Vitro

Outcome Measures

Primary Outcomes (1)

• Return of hormones produced by the ovarian tissue

  3 months after re-implantation

Secondary Outcomes (1)

• Development of egg(s) appropriate for use in in vitro fertilization

  Participants will be followed through their reproductive years (until the patient reaches 45 years of age)

Study Arms (1)

Retrieval and Cryopreservation

EXPERIMENTAL

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.

Procedure: Retrieval and Cryopreservation

Interventions

Retrieval and Cryopreservation 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.

Retrieval and Cryopreservation

Eligibility Criteria

• Age: 3 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (2)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Cryopreservation

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Study Officials

• Estil Strawn, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Division of Reproductive Endocrinology and Infertility

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: November 25, 2013
• Study Start: August 6, 2013
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

US (2)