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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT00417066 (opens ClinicalTrials.gov in a new tab)Other idpoor responders
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Overview

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

Greece

Start
Sept 2003
Primary completion
Not stated
Completion
Jul 2006
First posted
29 Dec 2006 (estimated)
Last update posted
16 Dec 2013 (estimated)
Conditions
Infertility · Premature Ovarian Failure

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20032004200520062007
  1. Ph 4

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

    NCT00417066

    Sept 2003 to Jul 2006

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 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.

Interventions

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

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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.

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.

Completed trials do not always post results.

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, 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 18403419

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: * regular menstrual cycle * 1 or more failed IVF attempts with poor response * 5 or fewer oocytes retrieved * FSH\>12 IU/l on day 3 Exclusion Criteria: * PCOS * Normal responders

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