Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 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: March 27, 2015
Last verified: March 2015
  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
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:


Further study details as provided by AZ Jan Palfijn Gent:

Primary Outcome Measures:
  • MII 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

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


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

  • 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


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Primary Completion Date: January 2016 (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
  • Body Mass Index (BMI) less than 32
  • PCOS patients

Exclusion Criteria:

  • endocrinal diseases or problems
  Contacts and Locations
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, see Learn About Clinical Studies.

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 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

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: March 27, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by AZ Jan Palfijn Gent:
OHSS
mataphase II oocytes (MII)
good quality embryo's
pregnancy

Additional relevant MeSH terms:
Deslorelin
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 25, 2015