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Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01683513
Recruitment Status : Unknown
Verified March 2017 by Dr. Decleer Wim, AZ Jan Palfijn Gent.
Recruitment status was:  Recruiting
First Posted : September 12, 2012
Last Update Posted : March 21, 2017
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent

Brief Summary:
In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/ ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and pregnancy rate.

Condition or disease Intervention/treatment Phase
Infertility PCOS Drug: GnRh agonist +1500E hCG Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients
Study Start Date : November 2011
Estimated Primary Completion Date : January 2018

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. MII oocytes [ Time Frame: patients will be followed during the stimulation with an average of 10 days ]
    The number of mature oocytes retrieved after stimulation without creating OHSS

  2. 2 Pro Nuclei (2PN) fertilization [ Time Frame: 24h after ICSI ]
    laboratory follow up of the fertilized egg during the first 24h

Secondary Outcome Measures :
  1. implantation rate [ Time Frame: 12 weeks ]
    The number of pregnancies obtained wich still is the most important issue for the patients

  2. OHSS [ Time Frame: one month with oocyte retrieval in the middle ]
    patient follow up according to subjective complaints and objective measures

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ICSI patients below 38 years
  • 1, 2 and 3e IVF cycle
  • Body Mass Index (BMI) less than 32
  • PCOS patients

Exclusion Criteria:

  • endocrinal diseases or problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01683513

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Contact: Wim Decleer 0032 9 3259220
Contact: Paul Devroey 0032 9 2248070

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AZ Jan Palfijn Recruiting
Gent, Oost-vlaanderen, Belgium, 9000
Contact: Wim Decleer, gynecologist    0032 9 2248853   
Contact    0032 9 2248851   
Principal Investigator: Wim Decleer, gynecologist         
Sub-Investigator: Kaan Osamanagaoglu, gynecologist, MD         
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
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Principal Investigator: Wim Decleer, gynecologist IVF Centrum Jan Palfijn Gent
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Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent Identifier: NCT01683513    
Other Study ID Numbers: Dr. Decleer W
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Keywords provided by Dr. Decleer Wim, AZ Jan Palfijn Gent:
mataphase II oocytes (MII)
good quality embryo's
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female