Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women
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|ClinicalTrials.gov Identifier: NCT05434936|
Recruitment Status : Suspended (Temporary protocol lapse)
First Posted : June 28, 2022
Last Update Posted : June 28, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Fertility Preservation||Procedure: Oophorectomy||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|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.|
|Masking:||None (Open Label)|
|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 :||August 11, 2017|
|Estimated Primary Completion Date :||October 10, 2022|
|Estimated Study Completion Date :||October 10, 2027|
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.
Patients undergoing surgery for any indicated procedure for fertility-threatening treatment will have attempt at collecting ovarian tissue at time of surgery.
- Effect of vitrification and slow freeze cryopreservation methods on follicular survival [ Time Frame: 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.
- Live birth rates in patients using cryopreserved ovarian tissue [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||13 Years to 42 Years (Child, Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05434936
|United States, Texas|
|Texas Children's Hospital Pavilion For Women|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Terri L Woodard, MD||Baylor College of Medicine|
|Responsible Party:||Terri Lynn Woodard, Associate Professor, Baylor College of Medicine|
|Other Study ID Numbers:||
|First Posted:||June 28, 2022 Key Record Dates|
|Last Update Posted:||June 28, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|