IMPLANT4: Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nolasiban 900 mg Nolasiban dispersible tablets for single oral administration |
Drug: Nolasiban
Nolasiban single oral administration
|
| Placebo Comparator: Placebo Placebo dispersible tablets for single oral administration |
Drug: Placebo
Placebo single oral administration
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Live birth [24 to 40 weeks of gestation]
Live birth after 24 weeks of gestation
- 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
Other Outcome Measures
- Adverse events [Through study completion, up to 11 months]
Treatment emergent adverse events frequency and severity
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site 1001 | Brussels | Belgium | ||
| 2 | Site 1003 | Brussels | Belgium | ||
| 3 | Site 1004 | Brussels | Belgium | ||
| 4 | Site 1002 | Brussel | Belgium | ||
| 5 | Site 1404 | Burnaby | Canada | ||
| 6 | Site 1401 | Montréal | Canada | ||
| 7 | Site 1402 | Toronto | Canada | ||
| 8 | Site 1403 | Toronto | Canada | ||
| 9 | Site 1107 | Olomouc | Czechia | ||
| 10 | Site 1101 | Praha | Czechia | ||
| 11 | Site 1102 | Praha | Czechia | ||
| 12 | Site 1103 | Praha | Czechia | ||
| 13 | Site 1104 | Praha | Czechia | ||
| 14 | Site 1105 | Praha | Czechia | ||
| 15 | Site 1108 | Praha | Czechia | ||
| 16 | Site 1110 | Praha | Czechia | ||
| 17 | Site 1109 | Teplice | Czechia | ||
| 18 | Site 1106 | Zlín | Czechia | ||
| 19 | Site 1205 | Herlev | Denmark | ||
| 20 | Site 1202 | Hvidovre | Denmark | ||
| 21 | Site 1204 | Kobenhavn | Denmark | ||
| 22 | Site 1203 | Skive | Denmark | ||
| 23 | Site 1302 | Tallinn | Estonia | ||
| 24 | Site 1301 | Tartu | Estonia | ||
| 25 | Site 1303 | Tartu | Estonia | ||
| 26 | Site 1504 | Berlin | Germany | ||
| 27 | Site 1506 | Berlin | Germany | ||
| 28 | Site 1505 | Bielefeld | Germany | ||
| 29 | Site 1501 | Heidelberg | Germany | ||
| 30 | Site 1502 | Lubeck | Germany | ||
| 31 | Site 1503 | Marburg | Germany | ||
| 32 | Site 1601 | Budapest | Hungary | ||
| 33 | Site 1603 | Budapest | Hungary | ||
| 34 | Site 1602 | Tapolca | Hungary | ||
| 35 | Site 1703 | Białystok | Poland | ||
| 36 | Site 1705 | Białystok | Poland | ||
| 37 | Site 1702 | Katowice | Poland | ||
| 38 | Site 1701 | Kraków | Poland | ||
| 39 | Site 1704 | Szczecin | Poland | ||
| 40 | Site 1706 | Warsaw | Poland | ||
| 41 | Site 1902 | Ekaterinburg | Russian Federation | ||
| 42 | Site 1901 | Moscow | Russian Federation | ||
| 43 | Site 1905 | Moscow | Russian Federation | ||
| 44 | Site 1904 | Samara | Russian Federation | ||
| 45 | Site 1805 | Barcelona | Spain | ||
| 46 | Site 1808 | Barcelona | Spain | ||
| 47 | Site 1809 | Leioa | Spain | ||
| 48 | Site 1804 | Madrid | Spain | ||
| 49 | Site 1807 | Madrid | Spain | ||
| 50 | Site 1811 | Sevilla | Spain |
Sponsors and Collaborators
- ObsEva SA
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18-OBE001-010