NCT00680238

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2004

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
Last Updated

May 20, 2008

Status Verified

May 1, 2008

Enrollment Period

3 years

First QC Date

May 15, 2008

Last Update Submit

May 19, 2008

Conditions

Infertility

Keywords

PregnancyimplantationmiscarriagesHLA-G

Outcome Measures

Primary Outcomes (1)

  • Pregnancy and implantation rates

    12 weeks

Secondary Outcomes (2)

  • Miscarriage rates

    9 months

  • Miscarriage rates

    9-11 day until βhCG

Study Arms (2)

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

Human derived FSHDRUG

Customized for each patient

Also known as: Bravelle
AB

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self paying ART patients

You may not qualify if:

  • Abnormal uterus
  • Specific Immunologic factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InfertilityAbortion, Spontaneous

Interventions

Urofollitropin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

MenotropinsGonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Thinus Kruger, M.D. PhD.

    University of Stellenbosch

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 20, 2008

Study Start

June 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

May 20, 2008

Record last verified: 2008-05