Infertility
Conditions
Keywords
IVF, ICSI
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.
Interventions
DRUGOBE001 dose 1
OBE001 dispersible tablets for single oral administration
DRUGOBE001 dose 2
OBE001 dispersible tablets for single oral administration
DRUGOBE001 dose 3
OBE001 dispersible tablets for single oral administration
DRUGPlacebo
Placebo dispersible tablets for single oral administration
Sponsors
ObsEva SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat | about 6 weeks post ET day | Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at about 6 weeks post ET day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EFFICACY ENDPOINTS Percentage of women with positive blood pregnancy test | 14 days post OPU day | Percentage of women with positive blood pregnancy test at 14 days post OPU day. |
| EFFICACY ENDPOINTS Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat | 10 weeks post OPU day | Percentage of women with an intra-uterine pregnancy with positive embryo heart-beat at 10 weeks post OPU day. |
| EFFICACY ENDPOINTS The embryo-implantation rate | 6 weeks post ET day | The embryo-implantation rate defined as the number of intra-uterine embryos with positive heart-beat at 6 weeks post ET day divided by the number of embryos transferred |
| EFFICACY ENDPOINTS Change from baseline to the time of ET in the rate of uterine contractions | at 3.5 hours after dose administration | Change from baseline to the time of ET in the rate of uterine contractions (UC/min). |
Other
| Measure | Time frame | Description |
|---|---|---|
| SAFETY ENDPOINTS (Haematology and biochemistry assessments) | 14 days post OPU day | Haematology and biochemistry assessments at screening and at visit V3 (14 days post OPU day) |
| PHARMACOKINETIC ENDPOINTS Plasma levels of OBE001 | at 3.5 hours after dose administration | Plasma levels of OBE001 |
| PHARMACOKINETIC-PHARMACODYNAMIC ENDPOINTS :Uterine contractions relationship to OBE001 plasma levels and pregnancy rate | up 10 weeks post OPU day | Uterine contractions relationship to OBE001 plasma levels and pregnancy rate |
| SAFETY ENDPOINTS Treatment emergent adverse events frequency and severity | up to 10 weeks post OPU day | Treatment emergent adverse events frequency and severity |
Countries
Belgium, Czechia, Denmark, Poland, Spain, United Kingdom
Outcome results
None listed