Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women

Sponsor

Baylor College of Medicine (Other)

Overall Status

Suspended

CT.gov ID

NCT05434936

Collaborator

(none)

Enrollment

Location

Arm

122

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fertility Preservation	Procedure: Oophorectomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 11, 2017

Anticipated Primary Completion Date :

Oct 10, 2022

Anticipated Study Completion Date :

Oct 10, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Effect of vitrification and slow freeze cryopreservation methods on follicular survival [5+ years]
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.

Secondary Outcome Measures

Live birth rates in patients using cryopreserved ovarian tissue [5+ years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female Patients only
0-42 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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Children's Hospital Pavilion For Women	Houston	Texas	United States	77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Terri Lynn Woodard, Associate Professor, Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT05434936

Other Study ID Numbers:

H-40808

First Posted:

Jun 28, 2022

Last Update Posted:

Jun 28, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Terri Lynn Woodard, Associate Professor, Baylor College of Medicine

oncofertility

Study Results

No Results Posted as of Jun 28, 2022