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Trial record 82 of 428 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00954265
Recruitment Status : Unknown
Verified August 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Active, not recruiting
First Posted : August 7, 2009
Last Update Posted : December 24, 2009
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by:
Universitair Ziekenhuis Brussel

Tracking Information
First Submitted Date  ICMJE August 6, 2009
First Posted Date  ICMJE August 7, 2009
Last Update Posted Date December 24, 2009
Study Start Date  ICMJE August 2005
Estimated Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
blastulation rate [ Time Frame: on day-5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00954265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
pregnancy rates, VEGF levels, OHSS rate [ Time Frame: 14 days after oocyte pick up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pregnancy Rates in IVF After Ovulation Triggering With Recombinant or Urinary Human Chorionic Gonadotrophin (HCG)
Official Title  ICMJE Phase III Study on the Effects of Recombinant HCG Ovulation Triggering on Stimulation, Embryonic and Pregnancy Parameters in an IVF Program
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Embryonic Development
  • Pregnancy
  • VEGF
Intervention  ICMJE
  • Drug: 10000 IU urinary HCG
    ovulation triggering
  • Drug: 250 mcg recombinant HCG
    ovulation triggering
Study Arms  ICMJE
  • Active Comparator: Urinary-HCG group
    These patients received u-HCG for ovulation triggering during ovarian stimulation for IVF
    Intervention: Drug: 10000 IU urinary HCG
  • Experimental: Recombinant HCG group
    These patients received rec-HCG for ovulation triggering during ovarian stimulation for IVF
    Intervention: Drug: 250 mcg recombinant HCG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 6, 2009)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2010
Estimated Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • endometriosis stage 3&4,
  • pco
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 36 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00954265
Other Study ID Numbers  ICMJE rec-HCG 002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Papanikolaou Evangelos, Centre for Reproductive Medicine
Study Sponsor  ICMJE Universitair Ziekenhuis Brussel
Collaborators  ICMJE Merck Serono International SA
Investigators  ICMJE
Study Director: Paul Devroey, Professor Professor or OB-GYN
PRS Account Universitair Ziekenhuis Brussel
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP