Clinical trial NCT03081208: Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI
Official title: A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Oral Administration of Nolasiban to Improve Pregnancy Rates Following IVF or ICSI in Day 3 and Day 5 Fresh Embryo Transfer Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: IVF
ICSI
Lead sponsor: ObsEva SA
Sponsor class: INDUSTRY
First posted: 2017-03-16
Enrollment: 810
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Key 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 phase support with vaginal micronized progesterone.
* Single, fresh D3 or D5 embryo transfer

Key Exclusion Criteria:

* Frozen-thawed embryo transfer
* More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
* Serum P4 greater than 1.5 ng/mL on the day of hCG administration

Primary outcomes:
measure: Intra-uterine pregnancy with fetal heart beat at 10 weeks
timeFrame: 10 weeks post ET day
Secondary outcomes:
measure: Live birth
timeFrame: Up to 42 weeks of gestation
measure: Miscarriage
timeFrame: From 6 weeks post ET to 24 weeks gestation
measure: Intra-uterine pregnancy at 6 weeks
timeFrame: 6 weeks post ET
measure: Positive blood pregnancy test
timeFrame: 14 days post OPU
Other outcomes:
measure: Adverse events
timeFrame: Through study completion, up to 11 months
measure: Neonatal assessments
timeFrame: Birth of infant until 28 days
measure: ASQ-3
timeFrame: 6 months after term
Locations:
city: Brussels
country: Belgium
facility: Investigator ID 1001
city: Brussels
country: Belgium
facility: Investigator ID 1002
city: Brussels
country: Belgium
facility: Investigator ID 1003
city: Brussels
country: Belgium
facility: Investigator ID 1004
city: Olomouc
country: Czechia
facility: Investigator ID 1107
city: Prague
country: Czechia
facility: Investigator ID 1101
city: Prague
country: Czechia
facility: Investigator ID 1102
city: Prague
country: Czechia
facility: Investigator ID 1103
city: Prague
country: Czechia
facility: Investigator ID 1104
city: Prague
country: Czechia
facility: Investigator ID 1108
city: Teplice
country: Czechia
facility: Investigator ID 1109
city: Zlin
country: Czechia
facility: Investigator ID 1106
city: Copenhagen
country: Denmark
facility: Investigator ID 1204
city: Herlev
country: Denmark
facility: Investigator ID 1205
city: Hvidovre
country: Denmark
facility: Investigator ID 1202
city: Skive
country: Denmark
facility: Investigator ID 1203
city: Tartu
country: Estonia
facility: Investigator ID 1301
city: Tartu
country: Estonia
facility: Investigator ID 1303
city: Helsinki
country: Finland
facility: Investigator ID 1401
city: Helsinki
country: Finland
facility: Investigator ID 1402
city: Oulu
country: Finland
facility: Investigator ID 1403
city: Heidelberg
country: Germany
facility: Investigator ID 1501
city: Lübeck
country: Germany
facility: Investigator ID 1502
city: Mainz
country: Germany
facility: Investigator ID 1504
city: Marburg
country: Germany
facility: Investigator ID 1503
city: Budapest
country: Hungary
facility: Investigator ID 1601
city: Budapest
country: Hungary
facility: Investigator ID 1604
city: Pécs
country: Hungary
facility: Investigator ID 1603
city: Tapolca
country: Hungary
facility: Investigator ID 1602
city: Białystok
country: Poland
facility: Investigator ID 1701
city: Białystok
country: Poland
facility: Investigator ID 1703
city: Białystok
country: Poland
facility: Investigator ID 1705
city: Katowice
country: Poland
facility: Investigator ID 1702
city: Szczecin
country: Poland
facility: Investigator ID 1704
city: Warsaw
country: Poland
facility: Investigator ID 1706
city: Barakaldo
country: Spain
facility: Investigator ID 1801
city: Barcelona
country: Spain
facility: Investigator ID 1805
city: Barcelona
country: Spain
facility: Investigator ID 1808
city: Leioa
country: Spain
facility: Investigator ID 1809
city: Madrid
country: Spain
facility: Investigator ID 1804
city: Madrid
country: Spain
facility: Investigator ID 1807
city: Sevilla
country: Spain
facility: Investigator ID 1811
city: Valencia
country: Spain
facility: Investigator ID 1806
Study officials:
affiliation: Geneva
name: ObsEva SA
role: STUDY_DIRECTOR
References:
citation: 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.