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Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent

Study Description
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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

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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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


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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01683513


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

Locations
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Belgium
AZ Jan Palfijn Recruiting
Gent, Oost-vlaanderen, Belgium, 9000
Contact: Wim Decleer, gynecologist    0032 9 2248853    wim.decleer@janpalfijngent.be   
Contact    0032 9 2248851    ivf.studie@janpalfijngent.be   
Principal Investigator: Wim Decleer, gynecologist         
Sub-Investigator: Kaan Osamanagaoglu, gynecologist, MD         
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
Investigators
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Principal Investigator: Wim Decleer, gynecologist IVF Centrum Jan Palfijn Gent
More Information
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Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov 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:
OHSS
mataphase II oocytes (MII)
good quality embryo's
pregnancy
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Prolactin Release-Inhibiting Factors
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs