Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women

NCT05434936 | Suspended

• 1 other identifier: H-40808
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare efficacy of ovarian tissue freezing using slow-freeze versus vitrification methods.

Conditions

Fertility Preservation

Keywords

oncofertility

Outcome Measures

Primary Outcomes (1)

• Effect of vitrification and slow freeze cryopreservation methods on follicular survival

  Investigators will explore and compare the impact of vitrification and slow freeze cryopreservation methods by evaluating follicular survival using classic histological analysis of follicular morphology.

  5+ years

Secondary Outcomes (1)

• Live birth rates in patients using cryopreserved ovarian tissue

  5+ years

Study Arms (1)

Collection

OTHER

There is only one arm of the study, all patients enrolled will have surgery in which the attempt will be made to collect ovarian tissue.

Procedure: Oophorectomy

Interventions

Oophorectomy PROCEDURE

Patients undergoing surgery for any indicated procedure for fertility-threatening treatment will have attempt at collecting ovarian tissue at time of surgery.

Collection

Eligibility Criteria

• Age: 0 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female Patients only
• years of age.
• Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy that places the patient at risk for impaired ovarian function and infertility 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 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.
• Signed an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian(s) must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.

You may not qualify if:

• Girls and women with psychological, psychiatric, or other conditions which prevent giving informed consent.
• Girls and women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
• Girls and women who are permanently menopausal, as documented by history and FSH levels.
• Girls and women who are pregnant.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital Pavilion For Women

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Ovariectomy

Intervention Hierarchy (Ancestors)

Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures

Study Officials

• Terri L Woodard, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a tissue bank protocol in which prospectively collected specimens of ovarian tissue and a sample of whole blood will be obtained from patients who elective to cryopreserve ovarian tissue to preserve fertility. The portion of tissue designated for patient use will be cryopreserved using the slow freeze method while the portion designated for research purposed will be divided and cryopreserved using the slow freeze versus vitrification methods.

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: June 28, 2022
• Study Start: August 11, 2017
• Primary Completion: October 10, 2025
• Study Completion (Estimated): October 10, 2027
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (1)