NCT00417183

Brief Summary

The purpose of this study is to compare the efficacy of two controlled ovarian stimulation protocols, the GnRH agonist protocol, widely known as the "long" protocol, and the flexible GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile patients receiving IVF treatment.

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
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2005

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

September 1, 2005

Completed
1.3 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
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 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

Infertility

Keywords

GnRH antagonistGnRH agonistLong protocolFlexible

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy per embryo transfer

Secondary Outcomes (3)

  • Biochemical pregnancy per embryo transfer

  • Clinical pregnancy per embryo transfer

  • Embryological data

Interventions

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

Eligibility Criteria

Age21 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-39 years
  • Body mass index 18-29 kg/m2
  • Menstrual cycle from 24-35 days
  • Normal basal FSH (\<10 IU/ml)
  • Normal basal LH (\<10 IU/ml)
  • Normal basal estradiol (\<80 pg/ml)

You may not qualify if:

  • Poor responder patients
  • Polycystic ovaries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eugonia

Athens, 11528, Greece

RECRUITING

Related Publications (1)

  • Lainas T, Zorzovilis J, Petsas G, Stavropoulou G, Cazlaris H, Daskalaki V, Lainas G, Alexopoulou E. In a flexible antagonist protocol, earlier, criteria-based initiation of GnRH antagonist is associated with increased pregnancy rates in IVF. Hum Reprod. 2005 Sep;20(9):2426-33. doi: 10.1093/humrep/dei106. Epub 2005 Jun 9.

    PMID: 15946995BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoateganirelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital 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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 29, 2006

Study Start

September 1, 2005

Study Completion

June 1, 2007

Last Updated

December 29, 2006

Record last verified: 2006-12

Locations

GR(1)