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

NCT ID: NCT00417066

Last Updated: 2013-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility Premature Ovarian Failure

Keywords

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poor responders GnRH antagonist GnRH agonist flare up short protocol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

Intervention Type DRUG

Arvekap 0.1mg (Triptorelin, Ipsen, France)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eugonia

OTHER

Sponsor Role lead

Principal Investigators

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Tryfon Lainas, PhD

Role: STUDY_DIRECTOR

Eugonia

Locations

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Eugonia

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 12638782 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18403419 (View on PubMed)

Other Identifiers

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poor responders

Identifier Type: -

Identifier Source: org_study_id