FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

Summary

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.

Timeline

Start

2014-01

Primary completion

2016-06

Completion

2017-08

Outcome

Missed primary endpoint

registry analysis (non-inferiority test); Fostimon® vs Gonal-F®; p = 0.49; Mean Difference (Final Values) -2.73 (95% CI -9.88 to 4.42); Fisher Exact NCT01969201 ↗

Drugs

Indications