The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.
The study is a prospective, randomised, parallel group, double-blind, placebo-controlled, Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
820
Ongoing pregnancy with fetal heart beat at 10 weeks
Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
Time frame: 10 weeks post ET day
Live birth
Live birth after 24 weeks of gestation
Time frame: 24 to 40 weeks of gestation
Clinical pregnancy at 6 weeks post ET day
Clinical pregnancy defined as intra-uterine pregnancy with fetal heart beat at 6 weeks post-ET day
Time frame: 6 weeks post ET
Pregnancy rate at 14 days post Oocyte Pick-up (OPU)
Positive blood pregnancy test at 14 days post OPU day
Time frame: 14 days post OPU
Pregnancy loss
Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation
Time frame: 6 weeks post ET to 24 weeks gestation
Plasma concentrations of nolasiban
Plasma concentrations of nolasiban after administration
Time frame: 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration
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