Clinical trial NCT02310802: OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI
Official title: A Phase 2, Double-blind, Dose-finding, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of OBE001 to Improve Embryo Implantation Following IVF or ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Keywords: IVF
ICSI
Lead sponsor: ObsEva SA
Sponsor class: INDUSTRY
First posted: 2014-12-08
Enrollment: 247
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 assess the increase in clinical pregnancy rate after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist, compared to placebo.

Detailed description: The study is a prospective, dose-finding, randomised, parallel group, double-blind, placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor antagonist OBE001 in 240 women undergoing embryo transfer following IVF or ICSI.

The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of active compound with placebo with regard to both efficacy and safety.

Eligibility criteria: Key Inclusion Criteria

1. Women with medically indicated IVF or ICSI using her own oocytes.
2. GnRH antagonist protocol, a single injection of hCG for triggering final follicular maturation and luteal phase support with vaginal micronized progesterone.
3. Evidence of uterine contractions by transvaginal ultrasound at baseline.

Key Exclusion Criteria

1. Blastocyst stage or frozen-thaw transfers
2. Clinically significant abnormalities in ECG, vital signs, physical examination or clinical laboratory results
3. Severe endometriosis and/or adenomyosis or risk of ovarian hyper stimulation syndrome

Primary outcomes:
measure: EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
timeFrame: about 6 weeks post ET day
Secondary outcomes:
measure: EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test
timeFrame: 14 days post OPU day
measure: EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat
timeFrame: 10 weeks post OPU day
measure: EFFICACY ENDPOINTS The embryo-implantation rate
timeFrame: 6 weeks post ET day
measure: EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions
timeFrame: at 3.5 hours after dose administration
Other outcomes:
measure: SAFETY ENDPOINTS Treatment emergent adverse events frequency and severity
timeFrame: up to 10 weeks post OPU day
measure: SAFETY ENDPOINTS (Haematology and biochemistry assessments)
timeFrame: 14 days post OPU day
measure: PHARMACOKINETIC ENDPOINTS Plasma levels of OBE001
timeFrame: at 3.5 hours after dose administration
measure: PHARMACOKINETIC-PHARMACODYNAMIC ENDPOINTS :Uterine contractions relationship to OBE001 plasma levels and pregnancy rate
timeFrame: up 10 weeks post OPU day
Locations:
city: Brussels
country: Belgium
city: Hradev Kralove
country: Czechia
city: Olomouc
country: Czechia
city: Prague
country: Czechia
city: Zlin
country: Czechia
city: Copenhagen
country: Denmark
city: Hvidovre
country: Denmark
city: Bialystok
country: Poland
city: Katowice
country: Poland
city: Szczecin
country: Poland
city: Warsaw
country: Poland
city: Alicante
country: Spain
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Sevilla
country: Spain
city: Vigo
country: Spain
city: London
country: United Kingdom
Study officials:
affiliation: ObsEva SA
name: Clinical Study Director
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.