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Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Eugonia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00417144
First Posted: December 29, 2006
Last Update Posted: December 29, 2006
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.
Information provided by:
Eugonia
  Purpose
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 Intervention Phase
Polycystic Ovary Syndrome Ovarian Hyperstimulation Syndrome Drug: Arvekap 0.1mg (Triptorelin, Ipsen, France) Drug: Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eugonia:

Primary Outcome Measures:
  • Development of OHSS
  • Ongoing pregnancy rate per embryo transfer

Secondary Outcome Measures:
  • Biochemical pregnancy
  • Clinical pregnancy
  • Embryological data

Estimated Enrollment: 200
Study Start Date: November 2003
Estimated Study Completion Date: May 2007
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.

  Eligibility

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.


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Normal responders
  • Poor responders
  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): NCT00417144


Contacts
Contact: Tryfon Lainas, PhD 00302107236333 ivf@eugonia.com.gr

Locations
Greece
Eugonia Recruiting
Athens, Greece, 11528
Contact: Tryfon Lainas, PhD    00302107236333    ivf@eugonia.com.gr   
Sponsors and Collaborators
Eugonia
Investigators
Principal Investigator: Tryfon Lainas, PhD Eugonia
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00417144     History of Changes
Other Study ID Numbers: ag vs antag PCOS
First Submitted: December 22, 2006
First Posted: December 29, 2006
Last Update Posted: December 29, 2006
Last Verified: December 2006

Keywords provided by Eugonia:
OHSS
PCOS
GnRH antagonist
GnRH agonist

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Ovarian Hyperstimulation Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Deslorelin
Triptorelin Pamoate
Ganirelix
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