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

Primary Purpose

Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome

Status

Unknown status

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

Arvekap 0.1mg (Triptorelin, Ipsen, France)

Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

About this trial

This is an interventional prevention trial for Polycystic Ovary Syndrome focused on measuring OHSS, PCOS, GnRH antagonist, GnRH agonist

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Normal responders
Poor responders

Sites / Locations

EugoniaRecruiting

Outcomes

Primary Outcome Measures

Development of OHSS

Ongoing pregnancy rate per embryo transfer

Secondary Outcome Measures

Biochemical pregnancy

Clinical pregnancy

Embryological data

Full Information

NCT ID

NCT00417144

First Posted

December 22, 2006

Last Updated

December 28, 2006

Sponsor

Eugonia

1. Study Identification

Unique Protocol Identification Number

NCT00417144

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Unknown status

Study Start Date

November 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Eugonia

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome

Keywords

OHSS, PCOS, GnRH antagonist, GnRH agonist

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Arvekap 0.1mg (Triptorelin, Ipsen, France)

Intervention Type

Drug

Intervention Name(s)

Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

Primary Outcome Measure Information:

Title

Development of OHSS

Title

Ongoing pregnancy rate per embryo transfer

Secondary Outcome Measure Information:

Title

Biochemical pregnancy

Title

Clinical pregnancy

Title

Embryological data

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic ovaries) Exclusion Criteria: Normal responders Poor responders

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tryfon Lainas, PhD

Phone

00302107236333

ivf@eugonia.com.gr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tryfon Lainas, PhD

Organizational Affiliation

Eugonia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eugonia

City

Athens

ZIP/Postal Code

11528

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tryfon Lainas, PhD

Phone

00302107236333

ivf@eugonia.com.gr

12. IPD Sharing Statement

Citations:

PubMed Identifier

12859048

Citation

Aboulghar MA, Mansour RT. Ovarian hyperstimulation syndrome: classifications and critical analysis of preventive measures. Hum Reprod Update. 2003 May-Jun;9(3):275-89. doi: 10.1093/humupd/dmg018.

Results Reference

background

PubMed Identifier

20008886

Citation

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. doi: 10.1093/humrep/dep436. Epub 2009 Dec 15.

Results Reference

derived

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

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