Effect of Oxytocin Antagonist on Reduction of Uterine Contractions (EFFORT)
|ClinicalTrials.gov Identifier: NCT01043120|
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : June 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|In Vitro Fertilisation (IVF) Treatment||Drug: Barusiban Drug: Placebo||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||February 2010|
|Primary Completion Date :||May 2010|
|Study Completion Date :||December 2010|
IV bolus of 20 mg for 1 minute followed by an IV infusion of 19 mg for up to 59 minutes. The maximum total duration of administration was 60 minutes.
|Placebo Comparator: Placebo||
IV bolus of saline (sodium chloride 0.9%) for 1 minute followed by an IV infusion of saline (sodium chloride 0.9%) for up to 59 minutes. Details on injection volume, infusion rates and doses are tabulated below.
- Frequency of uterine contractions, Intention-To-Treat (ITT) Analysis Set [ Time Frame: 30 minutes after start of dosing ]Frequency of uterine contractions was assessed by transvaginal ultrasound. The transvaginal ultrasound recordings were analysed for uterine contractions by a central independent assessor, blinded to treatment allocation.
- Frequency of uterine contractions, Per-Protocol (PP) Analysis Set [ Time Frame: 30 minutes after start of dosing ]Frequency of uterine contractions was assessed by transvaginal ultrasound. The transvaginal ultrasound recordings were analysed for uterine contractions by a central independent assessor, blinded to treatment allocation.
- Uterine contractile measures [ Time Frame: During and after dosing (one day) ]
- Inter-endometrial space [ Time Frame: 30 minutes after start of dosing ]
- Direction of Wave Propagation
- Direction of Wave Propagation, Post-hoc analysis [ Time Frame: 30 min after start of dosing and MET ]Post-hoc analyses of the secondary endpoint parameter wave propagation were conducted. The ability of the contractile waves to propagate uterine contractions after mock embryo transfer was categorised (No, Yes, Indeterminate, NA or NE) by the central assessor for the following time points: Pre-dose, 30 min after start of dosing and at end of mock embryo transfer (MET0 min). Fisher's exact p-value test comparing the distribution of No and Yes between treatment groups was performed
- Dispersion, Location, Distance from Point of Release and Velocity of Ultrasound Contrast Agent
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043120
|ISCARE IVF a.s.|
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|