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Pregnancy/Implantation Rates Using a Day 3 Score Versus Graduated Embryo Score Plus a Biochemical Marker (sHLA-G)

This study has been completed.
Sponsor:
Information provided by:
University of Stellenbosch
ClinicalTrials.gov Identifier:
NCT00680238
First received: May 15, 2008
Last updated: May 19, 2008
Last verified: May 2008
History of Changes

May 15, 2008
May 19, 2008
June 2004
June 2007   (final data collection date for primary outcome measure)
Pregnancy and implantation rates [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00680238 on ClinicalTrials.gov Archive Site
  • Miscarriage rates [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Miscarriage rates [ Time Frame: 9-11 day until βhCG ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pregnancy/Implantation Rates Using a Day 3 Score Versus Graduated Embryo Score Plus a Biochemical Marker (sHLA-G)
Pregnancy and Implantation Rates When Embryos Are Selected Based on a Single Day 3 Score (Day 3)vs Graduated Embryo Score(GES) Plus Soluble Human Leukocyte Antigen-G Expression.

Objective: To compare pregnancy rates and implantation rates when embryos are selected based on a single Day 3 (D.3) score vs. a GES score plus sHLA-G expression.

Comparing pregnancy rates and implantation rates when embryos are selected using the most common criteria for embryo selection on day 3 - the morphology-(number of blastomere, their shape and size and the percentage of fragmentation)vs a graduated embryo score accumulated over 72 hours and the expression of sHLA-G at 44-46 hours post fertilization.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Infertility
Drug: Human derived FSH
Customized for each patient
Other Name: Bravelle
  • No Intervention: A
    Embryo selection for transfer based on a Day 3 score only.
    Intervention: Drug: Human derived FSH
  • Active Comparator: B
    Embryos for transfer by first selecting any embryos that had a positive sHLA-G expression of OD = 190 ±6 and correlating such with the highest GES score available.
    Intervention: Drug: Human derived FSH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
214
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Self paying ART patients

Exclusion Criteria:

  • Abnormal uterus
  • Specific Immunologic factors
Female
25 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00680238
DKotze
Yes
Mr DJ Kotze, Stellenbosch University
University of Stellenbosch
Not Provided
Study Director: Thinus Kruger, M.D. PhD. University of Stellenbosch
University of Stellenbosch
May 2008

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