Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women

Fertility Preservation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05434936
• Other study ID #: H-40808
• Status: Suspended
• Phase: N/A
• Start date: August 11, 2017
• Est. completion date: October 10, 2027

Study information

• Verified date: June 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 24
• Est. completion date: October 10, 2027
• Est. primary completion date: October 10, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 0 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fertility Preservation

Intervention

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

Locations

Country	Name	City	State
United States	Texas Children's Hospital Pavilion For Women	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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