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Egg Freezing Pilot Study

This study has been completed.
Sponsor:
Information provided by:
University Reproductive Associates
ClinicalTrials.gov Identifier:
NCT00839839
First received: February 9, 2009
Last updated: July 20, 2011
Last verified: July 2011
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oocyte Cryopreservation in Assisted Reproduction

Resource links provided by NLM:


Further study details as provided by University Reproductive Associates:

Primary Outcome Measures:
  • Incidence of Biochemical Pregnancy

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

Estimated 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)
Intervention Details:
    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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Peter G. McGovern, MD, UMDNJ-NJMS
ClinicalTrials.gov Identifier: NCT00839839     History of Changes
Other Study ID Numbers: IRB 0120080226
Study First Received: February 9, 2009
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University Reproductive Associates:
infertility
egg freezing
fertility preservation

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

ClinicalTrials.gov processed this record on November 27, 2014