Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women

Baylor College of Medicine

Status: Suspended

Conditions: Fertility Preservation

Treatments: Procedure: Oophorectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05434936

H-40808

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: Under 42 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

Collection

Other group

Description:

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.

Treatment:

Procedure: Oophorectomy