The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.
The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
810
Nolasiban dispersible tablets for single oral administration
Placebo dispersible tablets for single oral administration
Intra-uterine pregnancy with fetal heart beat at 10 weeks
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: Up to 42 weeks of gestation
Miscarriage
Any clinical pregnancy that does not result in a live birth prior 24 weeks
Time frame: From 6 weeks post ET to 24 weeks gestation
Intra-uterine pregnancy at 6 weeks
Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day
Time frame: 6 weeks post ET
Positive blood pregnancy test
Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)
Time frame: 14 days post OPU
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigator ID 1001
Brussels, Belgium
Investigator ID 1002
Brussels, Belgium
Investigator ID 1003
Brussels, Belgium
Investigator ID 1004
Brussels, Belgium
Investigator ID 1107
Olomouc, Czechia
Investigator ID 1101
Prague, Czechia
Investigator ID 1102
Prague, Czechia
Investigator ID 1103
Prague, Czechia
Investigator ID 1104
Prague, Czechia
Investigator ID 1108
Prague, Czechia
...and 33 more locations