Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women

Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen

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

Study Overview

• Status: Suspended
• Conditions: Fertility Preservation
• Intervention / Treatment: Procedure: Oophorectomy

Detailed Description

The primary objective of this study is to determine the efficacy of ovarian tissue cryopreservation using slow-freeze and vitrification methods in enabling long-term preservation of ovarian function and fertility, in females undergoing treatment that may cause infertility. This study will provide study participants with their own tissue to cryopreserve and reserve for future use and:

• Determine the efficacy of ovarian cryopreservation techniques.
• Provide long-term follow up for patients who have undergone ovarian tissue cryopreservation for participants' own use.

In addition to providing study participants with the future opportunity to use their tissue with the intent to reinstate ovarian function, this study will provide research tissue to the embryology research lab at the Family Fertility Center at Texas Children's Hospital that will be used to:

• Optimize techniques for ovarian tissue cryopreservation of ovarian tissue for use in future retransplantation).
• Investigate factors affecting successful maturation and quality of immature oocytes obtained from ovarian tissue including growth factors, hormones and other culture conditions.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital Pavilion for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 42 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female Patients only
2. 0-42 years of age.
3. 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.
4. 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.
5. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Collection; 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; Patients undergoing surgery for any indicated procedure for fertility-threatening treatment will have attempt at collecting ovarian tissue at time of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth rates in patients using cryopreserved ovarian tissue	Investigators will explore reproductive outcomes of women using cryopreserved tissue by measuring the live birth rate as defined by the number of initial live births divided by the total number of ovarian tissue implantations performed.	5+ years

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Terri L Woodard, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2017
• Primary Completion (Estimated): October 10, 2025
• Study Completion (Estimated): October 10, 2027

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: oncofertility
• Other Study ID Numbers: H-40808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No