Co-adjuvant therapy in the luteal phase to facilitate implantation and pregnancy in women undergoing assisted reproductive technologies (i.e. IVF/ICSI with embryo transfer) MedDRA version: 9.1 Level: LLT Classification code 10061400 Term: Uterine contractions abnormal
Conditions
Interventions
Product Name: Barusiban
Product Code: FE 200440
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intraveno
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed informed consent form, prior to screening evaluations 2.Oocyte donors who have undergone controlled ovarian hyperstimulation in the long GnRH agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, have received hCG (= 5,000 IU urinary hCG or 250 µg recombinant hCG) for triggering final follicular maturation and have undergone oocyte retrieval (OR) in the current cycle 3.In good physical and mental health 4.Pre-menopausal, aged 18-35 years (both inclusive) 5.Body mass index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive) 6.Retrieval of = 6 cumulus-oocyte-complexes in the current controlled ovarian hyperstimulation cycle 7.Good visualisation of the entire volume of the uterus in the maximum longitudinal (mid-sagittal) plane from cervix to fundus, including the entire endometrium, myometrium and serosa at the transvaginal ultrasound at screening (Day OR +1) 8.Willing to not have sexual intercourse during the study and to either maintain sexual abstinence or to use a highly effective method of contraception (i.e. a failure rate of less than 1% per year, such as intrauterine device) from end-of-study until onset of next menses 9.Willing to not have intake of alcoholic beverages during the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Known clinically significant systemic diseases (e.g. insulin dependent diabetes) 2.Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study 3.Known current severe cardiac disease 4.Known history of hypertension or hypotension, or currently receiving medication to control blood pressure 5.Supine blood pressure, after resting for 5-10 minutes, outside a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside range of 50-90 mmHg on two consecutive measurements taken 5 minutes apart on Day OR +1 6.Past or current thrombophlebitis or venous thromboembolic disorders (including deep venous thrombosis); active or recent (within 1 year) arterial thromboembolic disease (e.g. stroke, myocardial infarction) 7.Known endometriosis stage I-IV 8.Moderate or severe ovarian hyperstimulation syndrome (OHSS) (according to Golan’s classification , ) in the current controlled ovarian hyperstimulation cycle 9.Known premature LH surge, defined as LH concentration = 10 IU/L and progesterone concentration = 1 ng/mL, in the current controlled ovarian hyperstimulation cycle 10.Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus 11.Undiagnosed vaginal bleeding 12.Currently breast feeding 13.Known current active pelvic inflammatory disease or vaginal infection 14.Uterine pathology (e.g. fibroids, polyps) documented at a transvaginal ultrasound within 3 months prior to randomisation 15.Previous major uterine surgery (e.g. myomectomy for leiomyomas), previous Caesarean section, congenital uterine abnormalities, or retained intrauterine device 16.Use of concomitant medications with utero-relaxant properties, such as calcium channel blockers (ATC code C08), beta-sympathomimetic agonists (ATC code R03), nitroglycerine (ATC code C01D), magnesium sulphate (ATC code B05X), potassium channel openers (ATC code C02D) and drugs for functional gastrointestinal disorders (ATC code A03) that could interfere with evaluation of the investigational medicinal products or uterine contractions, within 4 weeks before randomisation 17.Use of concomitant medications with uterotonic properties, such as dopamine (ATC code C01C), progesterone antagonists (ATC code G03XB) and prostaglandin analogues (ATC code A02B) that could interfere with evaluation of the investigational medicinal products or uterine contractions, within 4 weeks before randomisation 18.Treatment with anti-psychotics (ATC code N05A) or anti-depressants (ATC code N06) within 4 weeks before randomisation 19.Treatment with anxiolytics (ATC code N05B), hypnotics and sedatives (ATC code N05C) or continuous use of non-steroid anti-inflammatory drugs (NSAIDs), including aspirin, within 4 weeks before randomisation, with the exception of use in connection with oocyte retrieval 20.Sexual intercourse in the period from last day of ovarian stimulation to randomisation 21.Current or past (last 12 months) abuse of alcohol or drugs, and/or current (last month) use of alcohol of more than 7 units/week 22.Intake of alcoholic beverages on the day of screening or day of randomisation 23.Current or past (3 months) smoking of more than 10 cigarettes per day 24.History of chemotherapy (except for gestational conditions) or radiotherapy 25.Use of any non-registered investigational drug during 3 months before randomisation 26.Previous participation in the study 27.Hypersensitivity to any active ingr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of barusiban and atosiban compared to placebo on luteal phase uterine contractions in oocyte donors supplemented with progesterone;Secondary Objective: •To evaluate the effects of a mock embryo transfer on uterine contractions in oocyte donors exposed to barusiban, atosiban or placebo and supplemented with progesterone •To evaluate the effects of discontinuing barusiban, atosiban or placebo on uterine contractions •To explore the relationship between barusiban / atosiban concentrations and uterine contractions •To explore the pharmacokinetics of barusiban and atosiban •To evaluate the safety profile of barusiban and atosiban ;Primary end point(s): • Frequency of uterine contractions at 3h after start of dosing | — |
Countries
Belgium, Poland, Spain
Outcome results
None listed