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Ovarian Tissue Cryopreservation for Fertility Preservation in Girls and Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05434936
Recruitment Status : Suspended (Temporary protocol lapse)
First Posted : June 28, 2022
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Terri Lynn Woodard, Baylor College of Medicine

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : August 11, 2017
Estimated Primary Completion Date : October 10, 2022
Estimated Study Completion Date : October 10, 2027
Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   13 Years to 42 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Texas
Texas Children's Hospital Pavilion For Women
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Terri L Woodard, MD Baylor College of Medicine
More Information
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Responsible Party: Terri Lynn Woodard, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05434936    
Other Study ID Numbers: H-40808
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terri Lynn Woodard, Baylor College of Medicine:
oncofertility