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Endometrial Advancement After Rec or u-HCG Triggering

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00953628
First received: August 5, 2009
Last updated: September 1, 2009
Last verified: September 2009
History of Changes
  Purpose

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
Infertility
 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

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

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 for triggering ovulation Drug: 10000 IU urinary HCG
bolus 10000 units for ovulation triggering
Experimental: o Group B=recHCG for triggering ovulation Drug: 250 mcg recombinant HCG
bolus 250 mcg for ovulation triggering in IVF patients

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953628

Locations
Belgium
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, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00953628     History of Changes
Other Study ID Numbers: recHCG001
Study First Received: August 5, 2009
Last Updated: September 1, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:
endometrium
histology
pregnancy

Additional relevant MeSH terms:
Infertility
Adenoma
Genital Diseases, Male
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013