Pregnancy/Implantation Rates Using a Day 3 Score Versus G... | NCT00680238

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

NCT00680238

Sponsor

University of Stellenbosch

Status

Completed

Last Update Posted

May 20, 2008Estimated

Enrollment

214Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Human derived FSH

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

May 15, 2008

First Submission Date that Met QC Criteria

May 19, 2008

First Posted Date

May 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2008

Last Update Posted Date

May 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

214Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	No Intervention	Embryo selection for transfer based on a Day 3 score only.	Drug: Human derived FSH
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Human derived FSH	Drug	Customized for each patient	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy and implantation rates		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Miscarriage rates		9 months
Miscarriage rates		9-11 day until βhCG

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Self paying ART patients

Exclusion Criteria:

Abnormal uterus
Specific Immunologic factors

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thinus Kruger, M.D. PhD.	University of Stellenbosch	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D000022	Abortion, Spontaneous

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D050477	Urofollitropin

Ancestor Terms

ID	Term
D008596	Menotropins
D006065	Gonadotropins, Pituitary
D006062	Gonadotropins
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided