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Trial · Interventional

Status unknownPhase 4Registry data

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

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
200 participants
Sponsor
Eugonia · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Greece

Start
Nov 2003
Primary completion
Not stated
Completion
May 2007
First posted
29 Dec 2006 (estimated)
Last update posted
29 Dec 2006 (estimated)
Conditions
Polycystic Ovary Syndrome · Ovarian Hyperstimulation Syndrome

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200320042005200620072008
  1. Ph 4

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

    NCT00417144

    Nov 2003 to May 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

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

Arms0

The registry lists no arms for this trial.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Development of OHSS

  2. Ongoing pregnancy rate per embryo transfer

Secondary outcomes(3)
  1. Biochemical pregnancy

  2. Clinical pregnancy

  3. Embryological data

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLainas 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 20008886

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic ovaries) Exclusion Criteria: * Normal responders * Poor responders

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