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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2006 by Eugonia.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Eugonia

ClinicalTrials.gov Identifier:

NCT00417144

First received: December 22, 2006

Last updated: December 28, 2006

Last verified: December 2006

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Polycystic Ovary Syndrome

Drug Information available for: Gonadorelin Gonadorelin hydrochloride Deslorelin Triptorelin pamoate Ganirelix Ganirelix acetate

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 50 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Aboulghar MA, Mansour RT. Ovarian hyperstimulation syndrome: classifications and critical analysis of preventive measures. Hum Reprod Update. 2003 May-Jun;9(3):275-89. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Alexopoulou E, Kolibianakis EM. Flexible GnRH antagonist protocol versus GnRH agonist long protocol in patients with polycystic ovary syndrome treated for IVF: a prospective randomised controlled trial (RCT). Hum Reprod. 2010 Mar;25(3):683-9. Epub 2009 Dec 15.

ClinicalTrials.gov Identifier:	NCT00417144 History of Changes
Other Study ID Numbers:	ag vs antag PCOS
Study First Received:	December 22, 2006
Last Updated:	December 28, 2006
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Eugonia:

OHSS
PCOS
GnRH antagonist
GnRH agonist

Additional relevant MeSH terms:

Polycystic Ovary Syndrome
Ovarian Hyperstimulation Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Ganirelix
Triptorelin
Deslorelin

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013

To Top