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Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development

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ClinicalTrials.gov Identifier: NCT01422395
Recruitment Status : Completed
First Posted : August 24, 2011
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Main Line Fertility Center

August 22, 2011
August 24, 2011
June 4, 2014
August 2011
May 2013   (Final data collection date for primary outcome measure)
  • fertilization rate [ Time Frame: 18 hours after insemination ]
  • Embryo Quality [ Time Frame: day 3 and day 5 ]
  • Embryo Development [ Time Frame: Day 3 and day 5 ]
Same as current
Complete list of historical versions of study NCT01422395 on ClinicalTrials.gov Archive Site
Not Provided
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Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development
A Study to Compare Vitrified/Warmed Oocytes vs. Fresh Sibling Oocytes Collected Following Controlled Ovarian Stimulation Using Follistim AQ and Ganirelix Acetate on Fertilization Rates, Zygote Quality, Embryo Quality and Embryo Development
Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.
Not Provided
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Fertility
Procedure: Freezing
Vitrification
  • Experimental: freezing
    Intervention: Procedure: Freezing
  • No Intervention: No freezing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
May 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy
  • Day 2-4 FSH < 10 IU/ml, LH <12 IU/ml, and E2 <50 pg/ml
  • Antimullerian Hormone (AMH) >1.5
  • Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle
  • BMI >18 and <32

Exclusion Criteria:

  • Smokers
  • Polycystic Ovarian Syndrome (PCO)
Sexes Eligible for Study: Female
21 Years to 37 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01422395
MLFC-001
No
Not Provided
Not Provided
Main Line Fertility Center
Main Line Fertility Center
Merck Sharp & Dohme Corp.
Principal Investigator: Glassner J Michael, M.D. Main Line Fertility Center
Study Director: Sharon H. Anderson, Ph.D Main Line Fertility Center
Main Line Fertility Center
June 2014

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