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Fertility Preservation With Ovarian Tissue Freezing (PTO)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674164
Recruitment Status : Not yet recruiting
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Julio Saumet-Chilito, St. Justine's Hospital

Brief Summary:

The purpose of this study is to obtain ovarian tissue from female patients undergoing gonadotoxic treatments or gonadal ablating surgery, and that in consequence may see their future fertility impaired. Participants will be offered to preserve (freeze) and use ovarian tissue for the purpose of conceiving in the future.

Although, 86 live births have been reported with ovarian tissue cryo-preservation and grafting, the procedure is still considered experimental.

This research, will help us to learn and validate how to perform ovarian tissue cryo-preservation and thawing in the fertility preservation context.


Condition or disease Intervention/treatment Phase
Cancer Hematologic Disorder Infertility Ovarian Failure Other: Ovarian Cryopreservation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fertility Preservation With Ovarian Tissue Freezing
Estimated Study Start Date : September 10, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Intervention Details:
  • Other: Ovarian Cryopreservation
    Surgical ovarian removal and vitrification


Primary Outcome Measures :
  1. Cryopreservation of ovarian tissu by vitrification [ Time Frame: 5 years ]
    Measure the fertility rate of cryopreservation and grafting by ovarian tissue vitrification.



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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females, > 2 month and < 18 years of age
  2. Undergo surgery, chemotherapy, drug treatment, and/or radiation for the treatment or prevention of a medical condition or malignancy expected to result in permanent and complete loss of subsequent ovarian function.
  3. Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
  4. Subject may have newly diagnosed or recurrent disease.
  5. Subject who already has stored cryopreserved ovarian tissue in a frozen state prior to undergoing cancer treatments (surgery, chemotherapy or radiation) will be eligible for enrolment with informed consent.
  6. Subject not eligible to standard fertility preservation
  7. The subject and/or the subject's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies.

Exclusion Criteria:

  1. Women with psychological, psychiatric or other conditions which prevent giving fully informed consent.
  2. Women whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
  3. Women to whom the research intervention may decrease the survival or the treatment response to the underlying disease.
  4. AMH (Anti Müllerian Hormone) <0.016 ng/dl
  5. Women whose surgery is preformed outside the CHU Ste-Justine
  6. Patients eligible to a standard fertility preservation procedure.

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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): NCT03674164


Contacts
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Contact: Julio Saumet Chilito, MD 5143454931 ext 6323 julio.saumet.chilito@umontreal.ca

Locations
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Canada, Quebec
CHU Ste-Justine
Montréal, Quebec, Canada, H3X 1C6
Contact: Julio Saumet Chilito, MD    5143454931 ext 6323    julio.saumet.chilito@umontreal.ca   
Contact: Pascal Desrosier, BSC    5143454931 ext 6323    pascal.des.rosiers.hsj@ssss.gouv.qc.ca   
Sponsors and Collaborators
St. Justine's Hospital
Investigators
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Principal Investigator: Julio Saumet Chilito, MD Physician
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Responsible Party: Julio Saumet-Chilito, Physician, Director of fertility preservation department, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03674164    
Other Study ID Numbers: 217-1341
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Hematologic Diseases
Genital Diseases, Male
Genital Diseases, Female