NCT00417066

Brief Summary

The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes compared to the flare up protocol in this group of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
6 months 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
Last Updated

December 16, 2013

Status Verified

January 1, 2009

First QC Date

December 22, 2006

Last Update Submit

December 13, 2013

Conditions

InfertilityPremature Ovarian Failure

Keywords

poor respondersGnRH antagonistGnRH agonistflare upshort protocol

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate per embryo transfer

Secondary Outcomes (3)

  • Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.

  • Number of mature oocytes retrieved.

  • Number of fertilised oocytes.

Interventions

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

Eligibility Criteria

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

You may qualify if:

  • regular menstrual cycle
  • or more failed IVF attempts with poor response
  • or fewer oocytes retrieved
  • FSH\>12 IU/l on day 3

You may not qualify if:

  • PCOS
  • Normal responders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eugonia

Athens, 11528, Greece

Location

Related Publications (2)

  • Tarlatzis BC, Zepiridis L, Grimbizis G, Bontis J. Clinical management of low ovarian response to stimulation for IVF: a systematic review. Hum Reprod Update. 2003 Jan-Feb;9(1):61-76. doi: 10.1093/humupd/dmg007.

    PMID: 12638782BACKGROUND

  • Lainas TG, Sfontouris IA, Papanikolaou EG, Zorzovilis JZ, Petsas GK, Lainas GT, Kolibianakis EM. Flexible GnRH antagonist versus flare-up GnRH agonist protocol in poor responders treated by IVF: a randomized controlled trial. Hum Reprod. 2008 Jun;23(6):1355-8. doi: 10.1093/humrep/den107. Epub 2008 Apr 10.

    PMID: 18403419DERIVED

MeSH Terms

Conditions

InfertilityPrimary Ovarian Insufficiency

Interventions

ganirelixTriptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal 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

    STUDY DIRECTOR

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, 2003

Study Completion

July 1, 2006

Last Updated

December 16, 2013

Record last verified: 2009-01

Locations

GR(1)