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Egg Freezing Pilot Study

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ClinicalTrials.gov Identifier: NCT00839839
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Peter McGovern, MD, University Reproductive Associates

February 9, 2009
February 10, 2009
December 3, 2015
February 2009
June 2010   (Final data collection date for primary outcome measure)
Incidence of Biochemical Pregnancy [ Time Frame: 1 year ]
Incidence of Biochemical Pregnancy
Complete list of historical versions of study NCT00839839 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Egg Freezing Pilot Study
Oocyte Cryopreservation in Assisted Reproduction
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Infertility
  • Egg Freezing
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.
Experimental: Oocyte Vitrification
Intervention: Procedure: Oocyte Vitrification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Same as current
February 2011
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00839839
IRB 0120080226
No
Not Provided
Not Provided
Peter McGovern, MD, University Reproductive Associates
University Reproductive Associates
Not Provided
Principal Investigator: Peter G. McGovern, MD UMDNJ-NJMS
University Reproductive Associates
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP