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NCT00680238 Clinical Trial

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

Infertility Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00680238
Other study ID # DKotze
Secondary ID
Status Completed
Phase N/A
First received May 15, 2008
Last updated May 19, 2008
Start date June 2004
Est. completion date June 2007

Study information
Verified date May 2008
Source University of Stellenbosch
Contact n/a
Is FDA regulated No
Health authority South Africa: National Health Research Ethics Council
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 214
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria:

- Self paying ART patients

Exclusion Criteria:

- Abnormal uterus

- Specific Immunologic factors

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Drug:
• Human derived FSH
Customized for each patient

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Stellenbosch

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy and implantation rates 12 weeks No
Secondary Miscarriage rates 9 months No
Secondary Miscarriage rates 9-11 day until ßhCG No
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