A randomised, double-blind, parallel groups, placebo-controlled, multi-centre trial in oocyte donors assessing the effects of barusiban, a selective oxytocin antagonist, on uterine contractions on the day of embryo transfer - EFFORT

• Conditions: Co-adjuvant therapy in the luteal phase to prevent embryo expulsion and facilitate implantation and pregnancy in women undergoing assisted reproductive technologies (i.e. IVF/ICSI with embryo transfer); MedDRA version: 12.0Level: LLTClassification code 10061400Term: Uterine contractions abnormal

• Registration Number: EUCTR2009-012323-29-BE
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-10
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Signed informed consent form, prior to screening evaluations
2. Oocyte donors undergoing controlled ovarian hyperstimulation in the long GnRH agonist protocol or the multiple-dose GnRH antagonist protocol, having received hCG (10,000 IU urinary hCG or 250 µg recombinant hCG) for triggering final follicular maturation and having undergone oocyte retrieval (OR)
3. In good physical and mental health
4. Pre-menopausal, aged 18-37 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 uterus at the transvaginal ultrasound in the current controlled ovarian hyperstimulation cycle
8. Willing to not have sexual intercourse during the trial 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) from end-of-trial until onset of next menses
9. Willing to not have intake of alcoholic beverages during the trial

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

1. Any known clinically significant systemic disease (e.g., insulin dependent diabetes)
2. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial
3. Known current severe cardiac or pulmonary 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 the day of randomisation
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. Signs of moderate / 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. Uterine pathology (e.g., fibroids, polyps) documented at a transvaginal ultrasound within 3 months prior to randomisation
14. Previous major uterine surgery (e.g., myomectomy for leiomyomas), previous Caesarean section, congenital uterine abnormalities, or retained intrauterine device
15. Use of concomitant medications with utero-relaxant properties, such as progesterone (ATC code G03D), 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
16. 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
17. Treatment with anti-psychotics (ATC code N05A) or anti-depressants (ATC code N06A) within 4 weeks before randomisation
18. 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
19. Sexual intercourse in the period from last day of stimulation to randomisation
20. 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
21. Intake of alcoholic beverages on the day of randomisation
22. Current or past (3 months) smoking of more than 10 cigarettes per day
23. History of chemotherapy (except for gestational conditions) or radiotherapy
24. Hypersensitivity to any active ingredient or excipient in the medicinal products
25. Known current active pelvic inflammatory disease or vaginal infection
26. Hypersensi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effects of barusiban compared to placebo on uterine contractions on the day of embryo transfer.;Secondary Objective: • To evaluate the effects of barusiban compared to placebo on the movements of an ultrasound contrast agent administered during the mock embryo transfer <br>• To evaluate the safety profile of barusiban<br>;Primary end point(s): Frequency of uterine contractions at 30 min after start of dosing.