More than 1000 patients from fertility clinics across 9 European countries have been recruited, targeting randomization of at least 760 patients. IMPLANT2 enrollment has proceeded significantly ahead of plan, and initial results are now expected in the first quarter of 2018.
"We are very pleased to have completed recruitment for the IMPLANT2 study in only 6 months, significantly ahead of our original schedule, which we believe reflects the strong interest among both physicians and patients in improving fertility and pregnancy rates beyond currently available technologies." said Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of
About the IMPLANT2 Clinical Trial
IMPLANT2 is a Phase 3, randomized, double blind clinical trial assessing nolasiban compared to placebo on enhancing the rate of pregnancy in patients undergoing assisted reproduction by IVF or intracytoplasmic sperm injection (ICSI) due to low fertility. Following ovarian stimulation, egg retrieval and fertilization, eligible women are randomized to receive either a single oral dose of 900 mg nolasiban or placebo a few hours before Day 3 or Day 5 fresh embryo transfer (ET). The primary endpoint is ongoing pregnancy at 10 weeks after ET. Women with confirmed pregnancies will be monitored until live birth and the infants will be monitored for one to six months following birth.
About Assisted Reproductive Technology (ART)
Infertility affects about 10 percent of reproductive-aged couples, with approximately 1.6 million ART treatments (including IVF and ICSI) performed worldwide each year.
While the success of ART depends on multiple factors such as embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation. Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and blood flow to the uterus, may impair the implantation of the embryo.
Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live-birth among patients undergoing ART.
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