Fertility Preservation With Ovarian Tissue Freezing

NCT03674164 | Unknown

• 1 other identifier: 217-1341
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Hematologic Disorder; Infertility; Ovarian Failure

Outcome Measures

Primary Outcomes (1)

• Cryopreservation of ovarian tissu by vitrification

  Measure the fertility rate of cryopreservation and grafting by ovarian tissue vitrification.

  5 years

Interventions

Ovarian Cryopreservation OTHER

Surgical ovarian removal and vitrification

Eligibility Criteria

• Age: 2 Months - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females, \> 2 month and \< 18 years of age
• 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.
• Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
• Subject may have newly diagnosed or recurrent disease.
• 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.
• Subject not eligible to standard fertility preservation
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Ste-Justine

Montreal, Quebec, H3X 1C6, Canada

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Diseases; Infertility

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Julio Saumet Chilito, MD

  Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julio Saumet Chilito, MD

CONTACT

5143454931; julio.saumet.chilito@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Director of fertility preservation department

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: September 10, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)