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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.
Information provided by:
University of Stellenbosch Identifier:
First received: May 15, 2008
Last updated: May 19, 2008
Last verified: May 2008
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.

Condition Intervention
Drug: Human derived FSH

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Official Title: 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.

Further study details as provided by University of Stellenbosch:

Primary Outcome Measures:
  • Pregnancy and implantation rates [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Miscarriage rates [ Time Frame: 9 months ]
  • Miscarriage rates [ Time Frame: 9-11 day until βhCG ]

Enrollment: 214
Study Start Date: June 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Embryo selection for transfer based on a Day 3 score only.
Drug: Human derived FSH
Customized for each patient
Other Name: Bravelle
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.
Drug: Human derived FSH
Customized for each patient
Other Name: Bravelle

Detailed Description:
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.

Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Self paying ART patients

Exclusion Criteria:

  • Abnormal uterus
  • Specific Immunologic factors
  Contacts and Locations
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Please refer to this study by its identifier: NCT00680238

Sponsors and Collaborators
University of Stellenbosch
Study Director: Thinus Kruger, M.D. PhD. University of Stellenbosch
  More Information

Responsible Party: Mr DJ Kotze, Stellenbosch University Identifier: NCT00680238     History of Changes
Other Study ID Numbers: DKotze
Study First Received: May 15, 2008
Last Updated: May 19, 2008

Keywords provided by University of Stellenbosch:

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on May 25, 2017