CClinicalTrials.gg
Status unknownNCT00417183Updated Dec 29, 2006

Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation

A Phase 4 interventional study of Arvekap 0.1 mg (Triptorelin, Ipsen, France) and Ganirelix 0.25 (Orgalutran, Organon, The Netherlands) in Infertility, sponsored by Eugonia. Status unknown at 1 site in Greece. Open to female participants aged 21 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-12-29.

Sponsored by Eugonia · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
21 Years to 39 Years
Sex
Female
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Study 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.

Read the detailed description

The formulation of controlled ovarian stimulation protocols is one of the primary reasons for the successful development of IVF. The "long" GnRH agonist protocol, also known as the gold standard, has been widely used with considerable success. More recently, on the other hand, GnRH antagonist provide a new promising approach for endogenous gonadotrophin suppression by blocking the GnRH receptor. There is conflicting data in the literature regarding the relative merits of the two ovarian stimulation protocols.

COMPARISON: Pregnancy rates and embryological data will by assessed in IVF patients treated with either the "long" GnRH agonist (Arvekap) or the flexible GnRH antagonist (Ganirelix) protocol.

02

Conditions studied

  • Infertility

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Keywords

  • GnRH antagonist
  • GnRH agonist
  • Long protocol
  • Flexible
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 300 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Eugonia is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Poor responder patients
  • Polycystic ovaries
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants

Interventions

  • DrugArvekap 0.1 mg (Triptorelin, Ipsen, France)
  • DrugGanirelix 0.25 (Orgalutran, Organon, The Netherlands)
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What researchers measure

Primary outcomes

  1. Ongoing pregnancy per embryo transfer

Secondary outcomes

  1. Biochemical pregnancy per embryo transfer

  2. Clinical pregnancy per embryo transfer

  3. Embryological data

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Study locations

1 of 1 sites recruiting
  • Eugonia
    Athens, 11528, Greece
    Recruiting
08

References and documents

Publications

  • 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. PubMed 15946995 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00417183
Lead sponsor
Eugonia
First posted
Dec 29, 2006
Start date
Sep 2005
Completion
Jun 2007
Last update
Dec 29, 2006

Study contacts

Tryfon Lainas, PhD
Contact
ivf@eugonia.com.gr
00302107236333
Tryfon Lainas, PhD
principal investigator · Eugonia
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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