Infertility Clinical Trial
Official title:
A Phase 2, Double-blind, Dose-finding, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of OBE001 to Improve Embryo Implantation Following IVF or ICSI
The primary objective of this study is to assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.
The study is a prospective, dose-finding, randomised, parallel group, double-blind,
placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor
antagonist OBE001 in 240 women undergoing embryo transfer following IVF or ICSI.
The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation
of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of
active compound with placebo with regard to both efficacy and safety.
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