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Clinical Trial Summary

Despite the progression in assisted reproductive technology (ART), poor ovarian response to controlled ovarian stimulation remains a challenge for clinicians and a source of distress for patients. Multiple strategies have been tried to overcome these obstacles. The increase of the gonadotropin administration have been associated with a very low pregnancy rate. The introduction of GnRH agonist protocol, which takes advantage of the initial rise in endogenous gonadotropins that follows the agonist administration in the early follicular phase and subsequently prevents a premature LH surge, with fewer cycle cancellations, have improved cycle parameters and increased pregnancy rate. Recently, GnRH antagonists were introduced in ART treatment. They are effective in preventing a premature LH surge and allow for a more natural recruitment of follicles in the follicular phase in a non suppressed ovary. However, the randomized studies comparing the efficacy of these two regimens reported conflicting and nonsignificant results. Moreover, more recently adjuvant therapies for COH such as growth hormone therapy or pyridostigmine, oral L-arginine, and transdermal testosterone failed to improve IVF outcomes. Recently, the new treatment option with corifollitropin alfa, able to keep the circulating FSH level above the threshold necessary to support multi-follicular growth for an entire week, in a GnRH antagonist protocol seems to have a potential beneficial effect in poor responders.

The aim of this study is to compare long-acting FSH/GnRH antagonist with daily FSH/GnRH antagonist with short GnRH agonist protocol on IVF outcome in poor responder patients .


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02070198
Study type Interventional
Source Bioroma
Contact Mauro Schimberni, MD
Phone +39063334266
Email bioroma@bioroma.net
Status Recruiting
Phase Phase 4
Start date December 2013
Completion date December 2014

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