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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00954265
First Posted: August 7, 2009
Last Update Posted: December 24, 2009
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.
Collaborator:
Merck Serono International SA
Information provided by:
Universitair Ziekenhuis Brussel
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • blastulation rate [ Time Frame: on day-5 ]

Secondary Outcome Measures:
  • pregnancy rates, VEGF levels, OHSS rate [ Time Frame: 14 days after oocyte pick up ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 36 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954265


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:
Responsible Party: Dr Papanikolaou Evangelos, Centre for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT00954265     History of Changes
Other Study ID Numbers: rec-HCG 002
First Submitted: August 6, 2009
First Posted: August 7, 2009
Last Update Posted: December 24, 2009
Last Verified: August 2009

Keywords provided by Universitair Ziekenhuis Brussel:
pregnancy occurence
OHSS

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs