Infertility
Conditions
Keywords
IVF, ICSI, ART, ET
Brief summary
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.
Detailed description
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).
Interventions
DRUGNolasiban
Nolasiban single oral administration
DRUGPlacebo
Placebo single oral administration
Sponsors
ObsEva SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
* Indicated for IVF/ICSI in the context of assisted reproductive technology (ART) * Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal support with vaginal micronized progesterone. * Single fresh D5 embryo transfer
Exclusion criteria
* Frozen-thawed embryo transfer * Donor egg in the current transfer * More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle * Serum P4 greater than 1.5 ng/mL prior to hCG administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy with fetal heart beat at 10 weeks | 10 weeks post ET day | Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy at 6 weeks post ET day | 6 weeks post ET | Clinical pregnancy defined as intra-uterine pregnancy with fetal heart beat at 6 weeks post-ET day |
| Pregnancy rate at 14 days post Oocyte Pick-up (OPU) | 14 days post OPU | Positive blood pregnancy test at 14 days post OPU day |
| Pregnancy loss | 6 weeks post ET to 24 weeks gestation | Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation |
| Plasma concentrations of nolasiban | 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration | Plasma concentrations of nolasiban after administration |
| Live birth | 24 to 40 weeks of gestation | Live birth after 24 weeks of gestation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neonatal assessments | Birth of infant until 28 days | Incidence of any malformation or any significant morbidity during the neonatal period |
| Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire | 6 and 12 months after term | Screening questionnaire composed of 30 questions completed by the parent. Questions are divided into five areas: communication, gross motor, fine motor, problem solving and personal-social. Parents respond yes, sometimes and not yet to questions, these are converted to points 10, 5 and 0 for scoring and are totalled for each developmental area. These 5 area scores are compared with empirically derived cutoff points. |
| Adverse events | Through study completion, up to 11 months | Treatment emergent adverse events frequency and severity |
Countries
Belgium, Canada, Czechia, Denmark, Estonia, Germany, Hungary, Poland, Russia, Spain
Outcome results
None listed