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Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

This study is currently recruiting participants.
Verified March 2017 by Dr. Decleer Wim, AZ Jan Palfijn Gent
Sponsor:
ClinicalTrials.gov Identifier:
NCT01683513
First Posted: September 12, 2012
Last Update Posted: March 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent
  Purpose
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 Intervention Phase
Infertility PCOS Drug: GnRh agonist +1500E hCG Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Decleer Wim, AZ Jan Palfijn Gent:

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


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

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


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Primary Completion Date: January 2018 (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

Information from the National Library of Medicine

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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
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
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 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
Principal Investigator: Wim Decleer, gynecologist IVF Centrum Jan Palfijn Gent
  More Information

Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01683513     History of Changes
Other Study ID Numbers: Dr. Decleer W
First Submitted: August 23, 2012
First Posted: September 12, 2012
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:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Deslorelin
Triptorelin Pamoate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents