Clinical trial NCT05434936: Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women
Official title: Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women Facing a Fertility Threatening Medical Diagnosis or Treatment Regimen
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Fertility Preservation
Keywords: oncofertility
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 24
Sex: FEMALE
Minimum age (years): 0
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of vitrification and slow freeze cryopreservation methods on follicular survival
timeFrame: 5+ years
Secondary outcomes:
measure: Live birth rates in patients using cryopreserved ovarian tissue
timeFrame: 5+ years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital Pavilion For Women
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Terri L Woodard, MD
role: PRINCIPAL_INVESTIGATOR
References: