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

Sponsor:	University of Stellenbosch
Information provided by:	University of Stellenbosch
ClinicalTrials.gov Identifier:	NCT00680238

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:	Randomized, Single Blind (Subject), Parallel Assignment
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:

MedlinePlus related topics: Infertility Pregnancy Loss

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
A: No Intervention Embryo selection for transfer based on a Day 3 score only.	Drug: Human derived FSH Customized for each patient
B: Active Comparator 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

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 (South Africa)

More Information

No publications provided

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

Keywords provided by University of Stellenbosch:

Pregnancy
implantation
miscarriage
sHLA-G

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on February 08, 2010