NCT00417144

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 29, 2006

Status Verified

December 1, 2006

First QC Date

December 22, 2006

Last Update Submit

December 28, 2006

Conditions

Polycystic Ovary SyndromeOvarian Hyperstimulation Syndrome

Keywords

OHSSPCOSGnRH antagonistGnRH agonist

Outcome Measures

Primary Outcomes (2)

  • Development of OHSS

  • Ongoing pregnancy rate per embryo transfer

Secondary Outcomes (3)

  • Biochemical pregnancy

  • Clinical pregnancy

  • Embryological data

Interventions

Arvekap 0.1mg (Triptorelin, Ipsen, France)DRUG
Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Normal responders
  • Poor responders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eugonia

Athens, 11528, Greece

RECRUITING

Related Publications (2)

  • 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.

    PMID: 12859048BACKGROUND

  • 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.

    PMID: 20008886DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeOvarian Hyperstimulation Syndrome

Interventions

Triptorelin Pamoateganirelix

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Tryfon Lainas, PhD

    Eugonia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tryfon Lainas, PhD

CONTACT

00302107236333ivf@eugonia.com.gr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 29, 2006

Study Start

November 1, 2003

Study Completion

May 1, 2007

Last Updated

December 29, 2006

Record last verified: 2006-12

Locations

GR(1)