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

• Sponsor: Eugonia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00417144
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Nov 1, 2003
• Study Completion Date: May 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eugonia	Athens		Greece	11528

Sponsors and Collaborators

• Eugonia

Investigators

• Principal Investigator: Tryfon Lainas, PhD, Eugonia

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT00417144
• Other Study ID Numbers: ag vs antag PCOS
• First Posted: Dec 29, 2006
• Last Update Posted: Dec 29, 2006
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: OHSS; PCOS; GnRH antagonist; GnRH agonist
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome; Syndrome; Triptorelin Pamoate; Ganirelix

Study Results

No Results Posted as of Dec 29, 2006