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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
  Purpose

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
Infertility
 Drug: Human derived FSH

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Stellenbosch:

Primary Outcome Measures:
  • Pregnancy and implantation rates [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self paying ART patients

Exclusion Criteria:

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

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

No publications provided

Responsible Party: Mr DJ Kotze, Stellenbosch University
ClinicalTrials.gov Identifier: NCT00680238     History of Changes
Other Study ID Numbers: DKotze
Study First Received: May 15, 2008
Last Updated: May 19, 2008
Health Authority: South Africa: National Health Research Ethics Council

Keywords provided by University of Stellenbosch:
Pregnancy
implantation
miscarriage
sHLA-G

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

ClinicalTrials.gov processed this record on May 23, 2013