Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

This study has been completed.
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent Identifier:
First received: May 4, 2012
Last updated: February 3, 2015
Last verified: February 2015

The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.

Condition Intervention Phase
Drug: Decapeptyl Daily
Drug: pregnyl
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:
  • MII Oocytes [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    the number of mature oocytes retrieved

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

  • Patients With Cryopreserved Embryos [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: November 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: hCG
5000 IU Pregnyl SC
Drug: pregnyl
5000 IU SC
Active Comparator: hCG and GnRH agonist
5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC
Drug: Decapeptyl Daily
Decapeptyl 0.2 mg SC once 1day
Other Name: Gonapeptyl
Drug: pregnyl
5000 IU SC


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

Inclusion Criteria:

  • Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
  • 1,2 or 3 rd IVF-cycle

Exclusion Criteria:

  • polycystic ovary syndrome (PCOS) patients
  • patients with endocrinological diseases or problems
  Contacts and Locations
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Please refer to this study by its identifier: NCT01607203

A Z Jan Palfijn
Gent, Oost-vlaanderen, Belgium, 9000
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
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 Identifier: NCT01607203     History of Changes
Other Study ID Numbers: Dr. Decleer Wim
Study First Received: May 4, 2012
Results First Received: December 30, 2013
Last Updated: February 3, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by AZ Jan Palfijn Gent:
ovarian hyper stimulation syndrome (OHSS)
metaphase II oocytes (MII)
good quality embryo's

Additional relevant MeSH terms:
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on October 09, 2015