Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

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: NCT04616417
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Sana Salih, University of Illinois at Chicago

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a prospective study to assess the long term benefits and outcomes of the existing oocyte cryopreservation methods for fertility preservation in women with a potential medical or non medical risk of loss of fertility

Condition or disease Intervention/treatment Phase
Infertility, Female Deferred Childbearing Procedure: Investigational Oocyte Cryopreservation Not Applicable

Detailed Description:

This is a prospective study to assess the long term benefits and outcomes of the existing oocyte cryopreservation methods for fertility preservation in women with a potential medical or non medical risk of loss of fertility. Women wishing to preserve their oocytes using cryopreservation will be informed of the risk and limitations of the procedures involved in ovarian hyperstimulation, oocyte recovery, cryopreservation and subsequent viability after warming. Women who consent to the procedure will undergo standard controlled ovarian hyperstimulation (COH) and oocyte retrieval procedures currently in use for IVF. Following harvest all eggs obtained will be evaluated for degree of fragmentation and maturation status. The oocytes will be cryopreserved using kits of media and devices currently approved for use in the vitrification of fertilized eggs and embryos, and the cryopreserved oocytes will be stored for future patient use in a long term storage facility in Minnesota (Reprotech Ltd.). Patients with stored oocytes will be contacted annually to determine the outcome of any oocyte warming procedures (oocyte thawing, fertilization and embryo transfer).

We will obtain a structured fertility focused quality of life questionnaire (FertiQol) and survey to assess one year after harvest the impact of the process. We will compare cancer patients to those patients undergoing oocyte cryopreservation for non-medical reasons

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Investigational Oocyte Cryopreservation
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Investigational Oocyte Cryopreservation for Medical and Non Medical Indications
Actual Study Start Date : May 8, 2015
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2030
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Investigational Oocyte Cryopreservation
All subjects will undergo controlled ovarian hyperstimulation. They will be treated with variable dosages of injectable gonadotrophins over a period of 8 to 12 days. Response will be monitored using vaginal ultrasound and serum estradiol levels. When appropriate follicle maturation has been achieved, a single dose of human chorionic gonadotropin (hCG) will be administered to induce final oocyte maturation. Thirty-six hours after hCG administration, the subject will undergo standard transvaginal oocyte retrieval under ultrasound guidance. The procedure takes approximately 20 minutes and is carried out under conscious sedation with Fentanyl and Versed. The oocytes are immediately handed off to the embryology technicians in the IVF laboratory.
 Procedure: Investigational Oocyte Cryopreservation
Transvaginal oocyte retrieval under ultrasound guidance


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Assessing the impact of the process of oocyte cryopreservation [ Time Frame: 1 year ]
    Fertility focused quality of life questionnaire (FertiQol)

  2. Assessing the impact of the process of oocyte cryopreservation [ Time Frame: 1 year ]
    Structured interview

  3. Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation [ Time Frame: 1 year ]
    Fertility focused quality of life questionnaire (FertiQol)

  4. Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation [ Time Frame: 1 year ]
    Structured interview


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged >18 and < 40years
  • Women able to defer definitive cancer therapy for 21 to 30 days
  • Women diagnosed with cancer or any disease whose treatment or its progression may impair their reproductive potential (this would include but not be limited to cancer patients requiring treatment with chemotherapy or radiation, patients with rheumatologic diseases such as lupus, rheumatoid arthritis and ulcerative colitis and patients with genetic predisposition to cancers
  • Women undergoing standard In Vitro Fertilization to treat infertility who experience unforeseen events that halts the treatment cycle
  • Women seeking oocyte cryopreservation for non medical reasons, such as deferred childbearing
  • Women who are carriers of BRCA mutations predisposing them to cancer
  • Otherwise healthy females
  • Ability and willingness to comply with study protocol
  • Informed written consent, prior to any study-related procedure not part of normal care, with the understanding that the subject may withdraw consent at any time without prejudice to their future medical care

Exclusion Criteria:

  • Current pregnancy
  • Serum FSH > 10 mIU/ml for patients having egg freezing for a medical indication
  • Serum FSH > 10 mIU/ml for patients having egg freezing for social reasons
  • Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent (Post Traumatic Stress Disorder, severe depression, bipolar disorder, schizophrenia, severe anxiety and inability to cope)
  • Patients with extensive disease whose therapy is deemed palliative by the medical oncologist
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04616417


Contacts
Layout table for location contacts
Contact: Sana Salih, MD 312-355-3245 salih@uic.edu
Contact: Yesenia Vargas, RN 312-355-2740 Yvargas@uic.edu

Locations
Layout table for location information
United States, Illinois
University of Illinois Hospital & Health Sciences System - IVF Program in the Fertility Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Sana Salih, MD    312-355-3245    salih@uic.edu   
Contact: Yesenia Vargas, RN    312-355-2740    Yvargas@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Layout table for investigator information
Principal Investigator: Sana Salih, MD University of Illinois at Chicago
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sana Salih, Principal Investigator, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04616417    
Other Study ID Numbers: 2012-0233
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Infertility, Female