NCT00954265

Brief Summary

To access whether the ovulation triggering with rec-HCG instead urinary-HCG has any impact on the blastulation rate and pregnancy rate of patients undergoing IVF treatment

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 24, 2009

Status Verified

August 1, 2009

Enrollment Period

2.3 years

First QC Date

August 6, 2009

Last Update Submit

December 23, 2009

Conditions

Embryonic DevelopmentPregnancyVEGF

Keywords

pregnancy occurenceOHSS

Outcome Measures

Primary Outcomes (1)

  • blastulation rate

    on day-5

Secondary Outcomes (1)

  • pregnancy rates, VEGF levels, OHSS rate

    14 days after oocyte pick up

Study Arms (2)

Urinary-HCG group

ACTIVE COMPARATOR

These patients received u-HCG for ovulation triggering during ovarian stimulation for IVF

Drug: 10000 IU urinary HCG

Recombinant HCG group

EXPERIMENTAL

These patients received rec-HCG for ovulation triggering during ovarian stimulation for IVF

Drug: 250 mcg recombinant HCG

Interventions

10000 IU urinary HCGDRUG

ovulation triggering

Urinary-HCG group
250 mcg recombinant HCGDRUG

ovulation triggering

Recombinant HCG group

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • FSH\<12,
  • normal sperm,less than 36y,
  • single blastocyst transfer

You may not qualify if:

  • endometriosis stage 3\&4,
  • pco

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Reproductive Medicine, UZ Brussel

Brussels, Jette, 1090, Belgium

Location

MeSH Terms

Interventions

Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Paul Devroey, Professor

    Professor or OB-GYN

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 7, 2009

Study Start

August 1, 2005

Primary Completion

December 1, 2007

Study Completion

September 1, 2010

Last Updated

December 24, 2009

Record last verified: 2009-08

Locations

BE(1)