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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:
ClinicalTrials.gov Identifier:
NCT00680238
First Posted: May 20, 2008
Last Update Posted: May 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Stellenbosch
  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 (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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680238


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

Responsible Party: Mr DJ Kotze, Stellenbosch University
ClinicalTrials.gov Identifier: NCT00680238     History of Changes
Other Study ID Numbers: DKotze
First Submitted: May 15, 2008
First Posted: May 20, 2008
Last Update Posted: May 20, 2008
Last Verified: May 2008

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

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