Pregnancy Rates in IVF After Ovulation Triggering With Recombinant or Urinary Human Chorionic Gonadotrophin (HCG)

This study is ongoing, but not recruiting participants.

First Received: August 6, 2009 No Changes Posted

Sponsors and Collaborators:	Universitair Ziekenhuis Brussel Merck Serono International SA
Information provided by:	Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:	NCT00954265

Purpose

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

Condition	Intervention	Phase
Embryonic Development Pregnancy VEGF	Drug: 10000 IU urinary HCG Drug: 250 mcg recombinant HCG	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Study on the Effects of Recombinant HCG Ovulation Triggering on Stimulation, Embryonic and Pregnancy Parameters in an IVF Program

Resource links provided by NLM:

Drug Information available for: Chorionic gonadotropin

U.S. FDA Resources

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:

blastulation rate [ Time Frame: on day-5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pregnancy rates, VEGF levels, OHSS rate [ Time Frame: 14 days after oocyte pick up ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	August 2005
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Urinary-HCG group: Active Comparator These patients received u-HCG for ovulation triggering during ovarian stimulation for IVF	Drug: 10000 IU urinary HCG ovulation triggering
Recombinant HCG group: Experimental These patients received rec-HCG for ovulation triggering during ovarian stimulation for IVF	Drug: 250 mcg recombinant HCG ovulation triggering

Eligibility

Ages Eligible for Study:	20 Years to 36 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

endometriosis stage 3&4,
pco

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954265

Locations

Belgium, Jette
Centre for Reproductive Medicine, UZ Brussel
Brussels, Jette, Belgium, 1090

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Merck Serono International SA

Investigators

Study Director:

Paul Devroey, Professor

Professor or OB-GYN

More Information

Additional Information:

main web page of the centre for reproductive medicine in UZ Brussels This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Centre for Reproductive Medicine ( Dr Papanikolaou Evangelos )
Study ID Numbers:	rec-HCG 002
Study First Received:	August 6, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00954265 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:

pregnancy occurence
OHSS

Study placed in the following topic categories:

Chorionic Gonadotropin

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Reproductive Control Agents
Chorionic Gonadotropin
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009