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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Drug: Human derived FSH

• Registration Number: NCT00680238
• Lead Sponsor: University of Stellenbosch

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.

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 Timeline

• Study Start: 2004-06
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-05
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-19
• Last Update Submitted: 2008-05-19
• Study First Posted: 2008-05-20
• Last Update Posted: 2008-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 214

Inclusion Criteria

• Self paying ART patients

Exclusion Criteria

• Abnormal uterus
• Specific Immunologic factors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Human derived FSH	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.
A	Human derived FSH	Embryo selection for transfer based on a Day 3 score only.

Primary Outcome Measures

Name	Time	Method
Pregnancy and implantation rates	12 weeks

Secondary Outcome Measures

Name	Time	Method
Miscarriage rates	9-11 day until βhCG