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

Cancer Clinical Trial

Official title:

Ovarian Tissue Cryopreservation As A Means Of Preserving Ovarian Function in Females Undergoing Therapeutic Procedures That Will Potentially Lead To The Irreversible Loss of Ovarian Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993732
• Other study ID #: 126204
• Status: Completed
• Phase: N/A
• Start date: August 6, 2013
• Est. completion date: June 28, 2018

Study information

• Verified date: August 2019
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Auto Immune Disease
• Autoimmune Diseases
• Cancer
• Effects of Chemotherapy
• Immune System Diseases
• Unspecified Complication of Bone Marrow Transplant

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Froedtert and The Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return of hormones produced by the ovarian tissue		3 months after re-implantation
Secondary	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)