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InfertilityPhase 4NCT00417066

Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

A Phase 4 study testing Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) and Arvekap 0.1mg (Triptorelin, Ipsen, France) in people with Infertility and Premature Ovarian Failure, run by Eugonia at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Premature Ovarian Failure
What is being tested?
Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) and Arvekap 0.1mg (Triptorelin, Ipsen, France)
How many people
270 participants
Where
1 siteGreece
Study dates
Sep 2003to Jul 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • PCOS
  • Normal responders

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Eugonia

    Athens, 11528

Other trials in Greece

About this study

Official title: The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders

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.

Read the detailed description

Poor responders are women who fail to respond effectively to the usual gonadotropin stimulation protocol applied in an IVF cycle. It seems that a diminished ovarian reserve is the principal factor of poor ovarian response. Several strategies have been proposed for the management of poor responders, including flare up GnRH agonist regimens and the GnRH antagonist, which presents a new hope in this group of patients.

Comparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or flare up agonist (Arvekap) protocol. Primary outcomes compared will be ongoing pregnancy rates in the two treatment groups.

Being tested
Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands), Arvekap 0.1mg (Triptorelin, Ipsen, France)
Keywords
poor responders, GnRH antagonist, GnRH agonist, flare up, short protocol
Medical subject headings
Infertility, Primary Ovarian Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)Drug

  • Arvekap 0.1mg (Triptorelin, Ipsen, France)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ongoing pregnancy rate per embryo transfer

Secondary outcomes (3)

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

  2. Number of mature oocytes retrieved.

  3. Number of fertilised oocytes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2006 (estimated)
  2. Study startSep 2003
  3. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00417066
Sponsor's protocol ID
poor responders
Status last verified
Jan 2009
First submitted
22 Dec 2006
Last updated
16 Dec 2013
Results posted
No

Publications

  • 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.

    PubMed 12638782

  • 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.

    PubMed 18403419

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) and Arvekap 0.1mg (Triptorelin, Ipsen, France) in people with Infertility and Premature Ovarian Failure, run by Eugonia at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ongoing pregnancy rate per embryo transfer. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00417066, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.

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