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Low Dose hCG in the Late Follicular Phase

This study has been completed.
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT00750100
First received: September 9, 2008
Last updated: October 8, 2010
Last verified: September 2008
History of Changes

September 9, 2008
October 8, 2010
September 2007
January 2008   (final data collection date for primary outcome measure)
Number of oocytes in both treatment groups [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]
Number of oocytes in both treatment groups [ Time Frame: november 2008 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00750100 on ClinicalTrials.gov Archive Site
Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]
Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group [ Time Frame: november 2008 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Low Dose hCG in the Late Follicular Phase
Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?

In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Infertility
  • Drug: human chorionic gonadotropin
    hCG 200IU in the late follicular phase
    Other Name: Pregnyl, NV Organon, Oss, The Netherlands
  • Drug: recombinant gonadotropins
    200 IU per day during controlled ovarian stimulation
    Other Name: Puregon, NV Organon, Oss, The Netherlands
  • Active Comparator: A
    Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.
    Intervention: Drug: recombinant gonadotropins
  • Experimental: B
    Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.
    Intervention: Drug: human chorionic gonadotropin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
November 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • < 36 years on day of randomisation
  • FSH < 12 in the early follicular phase
  • Normal ultrasound scan
  • BMI between 18 and 29 (both inclusive)
  • Randomisation at outpatient clinic

Exclusion Criteria:

  • Endometriosis ≥ grade 3
  • PCO syndrome
  • Poor responder
  • Endocrine or metabolic abnormalities
Female
18 Years to 36 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00750100
EC REF 2006-157
No
Paul Devroey, Universitair Ziekenhuis Brussel
Universitair Ziekenhuis Brussel
Not Provided
Principal Investigator: Christophe Blockeel, MD UZ Brussel, Centre for Reproductive Medicine, Brussels
Universitair Ziekenhuis Brussel
September 2008

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