NCT00953628

Brief Summary

The purpose of this study is to investigate any potential advantages of replacing human chorionic gonadotropin (uhCG) with recombinant human chorionic gonadotropin (recHCG) for final oocyte maturation with regard to Ovarian hyperstimulation syndrome (OHSS)pathophysiology, endometrium receptivity and embryo quality and clinical pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

August 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

August 5, 2009

Last Update Submit

December 1, 2015

Conditions

Infertility

Keywords

endometriumhistologypregnancy

Outcome Measures

Primary Outcomes (1)

  • endometrium histology on the day of OPU

    day of oocytre pick up

Secondary Outcomes (1)

  • pregnancy rate

    14 days after oocyte pick up

Study Arms (2)

o Group A=uHCG ovul trig

ACTIVE COMPARATOR

HCG for triggering

Drug: 10000 IU urinary HCG

o Group B=recHCG ovul trig

EXPERIMENTAL

recombinant HCG for triggering

Drug: 250 mcg recombinant HCG

Interventions

10000 IU urinary HCGDRUG

bolus 10000 units for ovulation triggering

Also known as: Pregnyl
o Group A=uHCG ovul trig
250 mcg recombinant HCGDRUG

bolus 250 mcg for ovulation triggering in IVF patients

Also known as: Ovitrelle
o Group B=recHCG ovul trig

Eligibility Criteria

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

You may qualify if:

  • Less than 36 years old
  • Male or tubal infertility
  • FSH\<12 on day 3

You may not qualify if:

  • Endometriosis stage 3 \& 4

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

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

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 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Aristotle University Greece

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

August 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2008

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

BE(1)