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Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation 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: NCT00417144
Recruitment Status : Unknown
Verified December 2006 by Eugonia.
Recruitment status was:  Recruiting
First Posted : December 29, 2006
Last Update Posted : December 29, 2006
Information provided by:

Brief Summary:
The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Ovarian Hyperstimulation Syndrome Drug: Arvekap 0.1mg (Triptorelin, Ipsen, France) Drug: Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) Phase 4

Detailed Description:

Women with polycystic ovarian syndrome (PCOS) represent a group of patients at high risk of developing ovarian hyperstimulation syndrome (OHSS), an iatrogenic complication of ovarian stimulation during IVF treatment. In contrast to mild OHSS, severe OHSS is a life-threatening complication, characterized by massive ovarian enlargement, ascites, pleural effusion, oliguria, haemoconcentration and thromboembolic phenomena. Currently, no curative therapy for OHSS is available and thus prevention is considered the most effective “treatment”. Several measures have been adopted to reduce the occurrence of the syndrome, the most effective being cycle cancellation and withholding of human chorionic gonadotropin (hCG), which seems to be the most critical factor for the development of OHSS.

COMPARISON: This study aims to compare the development and severity of OHSS, as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist (Ganirelix) protocol vs a long GnRH agonist (Arvekap) protocol of ovarian stimulation.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients
Study Start Date : November 2003
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Development of OHSS
  2. Ongoing pregnancy rate per embryo transfer

Secondary Outcome Measures :
  1. Biochemical pregnancy
  2. Clinical pregnancy
  3. Embryological data

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic ovaries)

Exclusion Criteria:

  • Normal responders
  • Poor responders

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): NCT00417144

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Contact: Tryfon Lainas, PhD 00302107236333

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Eugonia Recruiting
Athens, Greece, 11528
Contact: Tryfon Lainas, PhD    00302107236333   
Sponsors and Collaborators
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Principal Investigator: Tryfon Lainas, PhD Eugonia

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00417144     History of Changes
Other Study ID Numbers: ag vs antag PCOS
First Posted: December 29, 2006    Key Record Dates
Last Update Posted: December 29, 2006
Last Verified: December 2006
Keywords provided by Eugonia:
GnRH antagonist
GnRH agonist
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Hyperstimulation Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
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
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists