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
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: human chorionic gonadotropin
Drug: recombinant gonadotropins
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: 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?

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Number of oocytes in both treatment groups [ Time Frame: up to 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: September 2007
Study Completion Date: November 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.
Drug: recombinant gonadotropins
200 IU per day during controlled ovarian stimulation
Other Name: Puregon, NV Organon, Oss, The Netherlands
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.
Drug: human chorionic gonadotropin
hCG 200IU in the late follicular phase
Other Name: Pregnyl, NV Organon, Oss, The Netherlands

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00750100

Locations
Belgium
UZ Brussel
Laarbeeklaan 101, Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Christophe Blockeel, MD UZ Brussel, Centre for Reproductive Medicine, Brussels
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Devroey, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT00750100     History of Changes
Other Study ID Numbers: EC REF 2006-157
Study First Received: September 9, 2008
Last Updated: October 8, 2010
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitair Ziekenhuis Brussel:
infertility
IVF
hCG
primary infertility
secondary infertility
patients requiring in-vitro fertilisation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014