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Egg Freezing Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839839
First Posted: February 10, 2009
Last Update Posted: December 3, 2015
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.
Information provided by (Responsible Party):
Peter McGovern, MD, University Reproductive Associates
  Purpose
University Reproductive Associates is conducting a pilot study to study the technique of egg freezing. Your participation in this study will provide us with important information to allow us to offer this technology for women wishing to freeze their eggs before cancer treatments. Your participation will include a standard IVF cycle with your eggs being frozen for a brief period of time and then transferred back to you as usual. You will receive a significant reduction in your IVF cycle cost.

Condition Intervention
Infertility Egg Freezing Procedure: Oocyte Vitrification

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oocyte Cryopreservation in Assisted Reproduction

Resource links provided by NLM:


Further study details as provided by Peter McGovern, MD, University Reproductive Associates:

Primary Outcome Measures:
  • Incidence of Biochemical Pregnancy [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Recovery of viable oocytes [ Time Frame: 1 year ]
  • incidence of fertilization [ Time Frame: one year ]
  • embryo development (how many fertilized eggs undergo development to a more advanced stage) [ Time Frame: 1 year ]
  • clinical pregnancy (fetal pole visible on transvaginal ultrasound) per cycle [ Time Frame: 1 year ]

Enrollment: 10
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oocyte Vitrification Procedure: Oocyte Vitrification
All oocytes retrieved will be vitrified (rapidly frozen) after egg retrieval. The oocytes will then be warmed on the same day and fertilized per standard IVF-ICSI. Resulting embryos will be transferred back to the patient as per protocol.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 10 women between the ages of 18-35 inclusive at time of signing Informed Consent Form.
  2. In good general health off of current medications which may confound response to study medications.
  3. Desire to seek pregnancy actively during the study period by IVF-ICSI.
  4. A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
  5. Ability to use the required medications.
  6. Day 3 FSH level < 12 IU/ml

Exclusion Criteria:

  1. Current pregnancy
  2. Patients with significant anemia (Hemoglobin < 10 mg/dL).
  3. Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
  Contacts and Locations
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): NCT00839839


Locations
United States, New Jersey
University Reproductive Associates
Hasbrouck Heights, New Jersey, United States, 07604
Sponsors and Collaborators
University Reproductive Associates
Investigators
Principal Investigator: Peter G. McGovern, MD UMDNJ-NJMS
  More Information

Additional Information:
Responsible Party: Peter McGovern, MD, Principal Investigator, University Reproductive Associates
ClinicalTrials.gov Identifier: NCT00839839     History of Changes
Other Study ID Numbers: IRB 0120080226
First Submitted: February 9, 2009
First Posted: February 10, 2009
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Peter McGovern, MD, University Reproductive Associates:
infertility
egg freezing
fertility preservation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female