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

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ClinicalTrials.gov Identifier: NCT00680238
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : May 20, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Infertility Drug: Human derived FSH

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
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.
Study Start Date : June 2004
Primary Completion Date : June 2007
Study Completion Date : June 2007
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: May 20, 2008    Key Record Dates
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