Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

This study is currently recruiting participants.
Verified May 2012 by AZ Jan Palfijn Gent
Sponsor:
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier:
NCT01607203
First received: May 4, 2012
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to see whether patients triggered with only hCG have higher number of M2-oocytes and implantation rate than patients triggered with hCG combined with GnRH agonist.


Condition Intervention Phase
Infertility
Drug: Decapeptyl / Gonapeptyl Daily
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

Resource links provided by NLM:


Further study details as provided by AZ Jan Palfijn Gent:

Primary Outcome Measures:
  • M2 oocytes [ Time Frame: patients will be followed during the stimulation with an average of 10 days ] [ Designated as safety issue: No ]
    the number of mature oocytes retrieved after stimulation without creating OHSS


Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    the number of pregnancies obtained, wich still is the most important issue for the patients


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: hCG
Active Comparator: hCG and GnRH agonist Drug: Decapeptyl / Gonapeptyl Daily
Decapeptyl 0.2 mg SC once 1day

  Eligibility

Ages Eligible for Study:   up to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICSI patients below 38 years
  • 1,2 or 3 rd IVF-cycle

Exclusion Criteria:

  • PCOS patients
  • patients with endocrinological diseases or problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607203

Contacts
Contact: Wim Decleer, gynacologist 0032 9 3259220 wim.decleer@janpalfijngent.be
Contact: Paul Devroey, professor 0032 9 2248070 ivf.studie@janpalfijngent.be

Locations
Belgium
A Z Jan Palfijn Recruiting
Gent, Oost-vlaanderen, Belgium, 9000
Contact: Wim Decleer, gynacologist    0032 9 2243024    wim.decleer@janpalfijngent.be   
Contact    0032 9 2248850    ivf.centrum@janpalfijngent.be   
Principal Investigator: Wim Decleer, gynacologist         
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
Investigators
Principal Investigator: Wim Decleer, gynacologist IVF Centrum Jan Palfijn Gent
  More Information

No publications provided

Responsible Party: Dr. Decleer Wim, gynaecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01607203     History of Changes
Other Study ID Numbers: Dr. Decleer Wim
Study First Received: May 4, 2012
Last Updated: May 24, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by AZ Jan Palfijn Gent:
OHSS
mature oocytes
good quality embryo's
implantation
pregnancy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Deslorelin
Triptorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014