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

Not Applicable

Completed

• Conditions: Cancer; Effects of Chemotherapy; Unspecified Complication of Bone Marrow Transplant; Auto Immune Disease
• Interventions: Procedure: Retrieval and Cryopreservation

• Registration Number: NCT01993732
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study Start: 2013-08-06
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Primary Completion: 2018-06-28
• Study Completion: 2018-06-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Retrieval and Cryopreservation	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.

Primary Outcome Measures

Name	Time	Method
Return of hormones produced by the ovarian tissue	3 months after re-implantation

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Froedtert and The Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States