Endometrial Advancement After Rec or u-HCG Triggering

This study has been completed.
Merck Serono International SA
Information provided by (Responsible Party):
Papanikolaou Evangelos, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
First received: August 5, 2009
Last updated: December 1, 2015
Last verified: December 2015
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.

Condition Intervention Phase
Drug: 10000 IU urinary HCG
Drug: 250 mcg recombinant HCG
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Endometrial Advancement After Rec or u-HCG Triggering

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • endometrium histology on the day of OPU [ Time Frame: day of oocytre pick up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: 14 days after oocyte pick up ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: August 2005
Estimated Study Completion Date: December 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: o Group A=uHCG ovul trig
HCG for triggering
Drug: 10000 IU urinary HCG
bolus 10000 units for ovulation triggering
Other Name: Pregnyl
Experimental: o Group B=recHCG ovul trig
recombinant HCG for triggering
Drug: 250 mcg recombinant HCG
bolus 250 mcg for ovulation triggering in IVF patients
Other Name: Ovitrelle

Detailed Description:
Biopsies of endometrium were taken in different groups Pregnancy rates were compared among defferent groups

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Endometriosis stage 3 & 4
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00953628

Centre for Reproductive Medicine, UZ Brussel
Brussels, Jette, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Merck Serono International SA
Study Director: Paul Devroey, Professor Professor or OB-GYN
  More Information

Additional Information:
Responsible Party: Papanikolaou Evangelos, Lecturer Aristotle University Greece, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00953628     History of Changes
Other Study ID Numbers: recHCG001 
Study First Received: August 5, 2009
Last Updated: December 1, 2015
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:

ClinicalTrials.gov processed this record on May 26, 2016