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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00417144
• Other study ID #: ag vs antag PCOS
• Status: Recruiting
• Phase: Phase 4
• First received: December 22, 2006
• Last updated: December 28, 2006
• Start date: November 2003
• Est. completion date: May 2007

Study information

• Verified date: December 2006
• Source: Eugonia
• Contact: Tryfon Lainas, PhD
• Phone: 00302107236333
• Email: ivf[@]eugonia.com.gr
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Normal responders

• Poor responders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Arvekap 0.1mg (Triptorelin, Ipsen, France)

• Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

Locations

Country	Name	City	State
Greece	Eugonia	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of OHSS
Primary	Ongoing pregnancy rate per embryo transfer
Secondary	Biochemical pregnancy
Secondary	Clinical pregnancy
Secondary	Embryological data