Clinical trial NCT03758885: Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
Official title: A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: IVF
ICSI
ART
ET
Lead sponsor: ObsEva SA
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 820
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
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 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).

Eligibility 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

Primary outcomes:
measure: Ongoing pregnancy with fetal heart beat at 10 weeks
timeFrame: 10 weeks post ET day
Secondary outcomes:
measure: Live birth
timeFrame: 24 to 40 weeks of gestation
measure: Clinical pregnancy at 6 weeks post ET day
timeFrame: 6 weeks post ET
measure: Pregnancy rate at 14 days post Oocyte Pick-up (OPU)
timeFrame: 14 days post OPU
measure: Pregnancy loss
timeFrame: 6 weeks post ET to 24 weeks gestation
measure: Plasma concentrations of nolasiban
timeFrame: 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration
Other outcomes:
measure: Adverse events
timeFrame: Through study completion, up to 11 months
measure: Neonatal assessments
timeFrame: Birth of infant until 28 days
measure: Ages and Stages Questionnaires® (ASQ-3™) 6 and 12 month Questionnaire
timeFrame: 6 and 12 months after term
Locations:
city: Brussels
country: Belgium
facility: Site 1001
city: Brussels
country: Belgium
facility: Site 1003
city: Brussels
country: Belgium
facility: Site 1004
city: Brussel
country: Belgium
facility: Site 1002
city: Burnaby
country: Canada
facility: Site 1404
city: Montréal
country: Canada
facility: Site 1401
city: Toronto
country: Canada
facility: Site 1402
city: Toronto
country: Canada
facility: Site 1403
city: Olomouc
country: Czechia
facility: Site 1107
city: Praha
country: Czechia
facility: Site 1101
city: Praha
country: Czechia
facility: Site 1102
city: Praha
country: Czechia
facility: Site 1103
city: Praha
country: Czechia
facility: Site 1104
city: Praha
country: Czechia
facility: Site 1105
city: Praha
country: Czechia
facility: Site 1108
city: Praha
country: Czechia
facility: Site 1110
city: Teplice
country: Czechia
facility: Site 1109
city: Zlín
country: Czechia
facility: Site 1106
city: Herlev
country: Denmark
facility: Site 1205
city: Hvidovre
country: Denmark
facility: Site 1202
city: Kobenhavn
country: Denmark
facility: Site 1204
city: Skive
country: Denmark
facility: Site 1203
city: Tallinn
country: Estonia
facility: Site 1302
city: Tartu
country: Estonia
facility: Site 1301
city: Tartu
country: Estonia
facility: Site 1303
city: Berlin
country: Germany
facility: Site 1504
city: Berlin
country: Germany
facility: Site 1506
city: Bielefeld
country: Germany
facility: Site 1505
city: Heidelberg
country: Germany
facility: Site 1501
city: Lubeck
country: Germany
facility: Site 1502
city: Marburg
country: Germany
facility: Site 1503
city: Budapest
country: Hungary
facility: Site 1601
city: Budapest
country: Hungary
facility: Site 1603
city: Tapolca
country: Hungary
facility: Site 1602
city: Białystok
country: Poland
facility: Site 1703
city: Białystok
country: Poland
facility: Site 1705
city: Katowice
country: Poland
facility: Site 1702
city: Kraków
country: Poland
facility: Site 1701
city: Szczecin
country: Poland
facility: Site 1704
city: Warsaw
country: Poland
facility: Site 1706
city: Ekaterinburg
country: Russian Federation
facility: Site 1902
city: Moscow
country: Russian Federation
facility: Site 1901
city: Moscow
country: Russian Federation
facility: Site 1905
city: Samara
country: Russian Federation
facility: Site 1904
city: Barcelona
country: Spain
facility: Site 1805
city: Barcelona
country: Spain
facility: Site 1808
city: Leioa
country: Spain
facility: Site 1809
city: Madrid
country: Spain
facility: Site 1804
city: Madrid
country: Spain
facility: Site 1807
city: Sevilla
country: Spain
facility: Site 1811
Study officials:
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.