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Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

This study is currently recruiting participants.
Verified September 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:
NCT01683513
First received: August 23, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

In this study the investigators compare the traditional way of triggering with a new way in PCOS patients. This to reduce the risque of OHSS in IVF/ ICSI treatment. The investigators also compare the number of oocytes, embryo's and pregnancy rate.


Condition Intervention Phase
Infertility
PCOS
 Drug: GnRh agonist +1500E hCG
 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: Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

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

  • 2PN fertilization [ Time Frame: 24h after ICSI ] [ Designated as safety issue: No ]
    laboratory follow up of the fertilized egg during the first 24h

  • OHSS [ Time Frame: one month with oocyte retrieval in the middle ] [ Designated as safety issue: Yes ]
    patient follow up according to subjective complaints and objective measures


Secondary Outcome Measures:
  • implantation 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: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: humaan chorion gonadotropine
ovulation induction with 5000E hCG
Active Comparator: GnRH agonist + 1500E hCG
ovulation induction with GnRH agonist and 1500E hCG one hour after egg retrieval
 Drug: GnRh agonist +1500E hCG
ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICSI patients below 38 years
  • 1, 2 and 3e IVF cycle
  • BMI < 32
  • PCOS patients

Exclusion Criteria:

  • endocrinal diseases or problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683513

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

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

No publications provided

Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01683513     History of Changes
Other Study ID Numbers: Dr. Decleer W
Study First Received: August 23, 2012
Last Updated: September 7, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by AZ Jan Palfijn Gent:
OHSS
mature oocytes
good quality embryo's
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 June 17, 2013