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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nolasiban 900 mg | Experimental | Nolasiban dispersible tablets for single oral administration |
|
| Placebo | Placebo Comparator | Placebo dispersible tablets for single oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nolasiban | Drug | Nolasiban single oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 weeks post ET day |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | Live birth after 24 weeks of gestation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Treatment emergent adverse events frequency and severity | Through study completion, up to 11 months |
| Neonatal assessments | Incidence of any malformation or any significant morbidity during the neonatal period |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1001 | Brussels | Belgium | ||||
| Site 1002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33534895 | Derived | Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369. |
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| Placebo |
| Drug |
Placebo single oral administration |
|
| 6 weeks post ET |
| Pregnancy rate at 14 days post Oocyte Pick-up (OPU) | Positive blood pregnancy test at 14 days post OPU day | 14 days post OPU |
| Pregnancy loss | Pregnancy loss at 6 or 10 weeks after ET and before 24 weeks of gestation | 6 weeks post ET to 24 weeks gestation |
| Plasma concentrations of nolasiban | Plasma concentrations of nolasiban after administration | 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration |
| Birth of infant until 28 days |
| Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire | 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. | 6 and 12 months after term |
| Brussels |
| Belgium |
| Site 1003 | Brussels | Belgium |
| Site 1004 | Brussels | Belgium |
| Site 1404 | Burnaby | Canada |
| Site 1401 | Montreal | Canada |
| Site 1402 | Toronto | Canada |
| Site 1403 | Toronto | Canada |
| Site 1107 | Olomouc | Czechia |
| Site 1101 | Prague | Czechia |
| Site 1102 | Prague | Czechia |
| Site 1103 | Prague | Czechia |
| Site 1104 | Prague | Czechia |
| Site 1105 | Prague | Czechia |
| Site 1108 | Prague | Czechia |
| Site 1110 | Prague | Czechia |
| Site 1109 | Teplice | Czechia |
| Site 1106 | Zlín | Czechia |
| Site 1204 | Copenhagen | Denmark |
| Site 1205 | Herlev | Denmark |
| Site 1202 | Hvidovre | Denmark |
| Site 1203 | Skive | Denmark |
| Site 1302 | Tallinn | Estonia |
| Site 1301 | Tartu | Estonia |
| Site 1303 | Tartu | Estonia |
| Site 1504 | Berlin | Germany |
| Site 1506 | Berlin | Germany |
| Site 1505 | Bielefeld | Germany |
| Site 1501 | Heidelberg | Germany |
| Site 1502 | Lübeck | Germany |
| Site 1503 | Marburg | Germany |
| Site 1601 | Budapest | Hungary |
| Site 1603 | Budapest | Hungary |
| Site 1602 | Tapolca | Hungary |
| Site 1703 | Bialystok | Poland |
| Site 1705 | Bialystok | Poland |
| Site 1702 | Katowice | Poland |
| Site 1701 | Krakow | Poland |
| Site 1704 | Szczecin | Poland |
| Site 1706 | Warsaw | Poland |
| Site 1901 | Moscow | Russia |
| Site 1905 | Moscow | Russia |
| Site 1904 | Samara | Russia |
| Site 1902 | Yekaterinburg | Russia |
| Site 1805 | Barcelona | Spain |
| Site 1808 | Barcelona | Spain |
| Site 1809 | Leioa | Spain |
| Site 1804 | Madrid | Spain |
| Site 1807 | Madrid | Spain |
| Site 1811 | Seville | Spain |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000618265 | nolasiban |
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