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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 because the information has not been verified recently.
Verified August 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:
NCT00954265
First received: August 6, 2009
Last updated: December 23, 2009
Last verified: August 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Dr Papanikolaou Evangelos, Centre for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT00954265     History of Changes
Other Study ID Numbers: rec-HCG 002
Study First Received: August 6, 2009
Last Updated: December 23, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:
pregnancy occurence
OHSS

Additional relevant MeSH terms:
Chorionic Gonadotropin
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014