- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00587327
Effect of Oxytocin and Vasopressin Antagonists on Uterine Contractions (OVANCON)
A Randomised, Double-blind, Parallel Groups, Placebo-controlled, Multi-centre Study Assessing the Effects of a Selective Oxytocin Antagonist (Barusiban) and a Mixed Oxytocin Antagonist - Vasopressin V1a Antagonist (Atosiban) Administered Intravenously on Luteal Phase Uterine Contractions in Oocyte Donors Supplemented With Vaginal Progesterone
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a randomised, double-blind, parallel groups, placebo-controlled, multi-centre trial. It was designed to evaluate the effects of a selective oxytocin antagonist (barusiban) and a mixed oxytocin antagonist - vasopressin V1a antagonist (atosiban) on uterine contractions during the luteal phase. Participants in this trial were oocyte donors who had undergone controlled ovarian hyperstimulation in the long gonadotrophin-releasing hormone (GnRH) agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, received hCG for triggering of final follicular maturation and undergone oocyte retrieval (OR). The duration of the trial was five days and participants attended the clinic on three occasions: Day OR +1 (screening), Day OR +2 (randomisation and dosing of investigational medicinal product), and Day OR +5 (end-of-trial).
After screening on Day OR +1, participants initiated luteal support supplementation with vaginal progesterone, which continued throughout the trial. On Day OR +2, participants were randomised to either barusiban, atosiban or placebo and participants received an intravenous (IV) bolus followed by an IV infusion of either barusiban, atosiban or placebo for approximately 4h. A mock embryo transfer was performed 3h after start of dosing.
Uterine contractility parameters were assessed by transvaginal ultrasound. The transvaginal ultrasound recordings were analysed for uterine contractions by a central independent assessor, blinded to treatment allocation
Definitions:
The frequency of uterine contractions was defined as the number of uterine contractions per minute. A contraction was defined as one sequential upward and downward vertical displacement of the endometrial / myometrial interface over time.
The external contractile measure was the mean wave amplitude in mm at the lumenal surface. This metric was measured at the lumenal peaks and troughs only and was a measurement designed to study the relationship between endometrial wave activity, manifested as bulk motion of the uterus, versus internal contractile strength. The external contractile measure was reported in mm/contraction.The external contractile measure quantified the movement of the uterus as a whole as measured at the lumen, i.e. the motion of the uterus relative to the body.
The internal contractile measure was the strength of the contractions based upon the sum of the contraction amplitudes measured at the anterior and posterior endometrial / myometrial interfaces. The amplitude at each interface was defined as the average difference between the endometrial / myometrial-lumenal distance measured at the peaks and troughs of the endometrial / myometrial interfaces. The internal contractile measure was reported in mm/contraction. The internal contractile measure quantified the movement of the endometrium relative to the lumen, i.e. the motion internal to the uterus.
The total contractile measure was the sum of the external contractile measure and the internal contractile measure and quantified total muscle movement in the uterus. If the waves at the anterior and posterior endometrial / myometrial interfaces were in phase then there was no endometrial motion relative to the lumen and the motion was a pure wave motion with the internal contractile measure equal to zero. The total contractile measure was reported in mm/contraction.
Inter-subendometrial space was measured as the distance between the anterior stratum basalis and posterior stratum basalis layers in mid-sagittal plane at an anatomic location between 5 and 10 mm from the fundus. All inter-subendometrial space measurements were made by selecting a clear image of the uterus, waiting for any contractions to pass and freezing the image.
A linear distance measurement was then taken between the anatomic landmarks described above. Inter-subendometrial space was calculated from existing measurements using the mean of all measurements identifying the endometrial-myometrial interfaces on the superior and inferior surfaces in each endometrial strip when the arrows identifying endometrial contractions were placed for motion analysis. Inter-subendometrial space was reported in mm
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Saline solution for IV administration.
Bolus and infusion for 4 hours.
|
Experimental: Barusiban
|
Solution for IV treatment.
Bolus and infusion for 4 hours
|
Experimental: Atosiban
|
Solution for IV administration.
Bolus and infusion for 4 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of uterine contractions
Time Frame: 3h after start of dosing
|
3h after start of dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions
Time Frame: 3h after start of dosing
|
3h after start of dosing
|
Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions
Time Frame: 5 min, 15 min, 30 min, 1h, 1h 30 min, 2h, and 2h 30 min after start of dosing
|
5 min, 15 min, 30 min, 1h, 1h 30 min, 2h, and 2h 30 min after start of dosing
|
Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions
Time Frame: 5 min, 30 min, and 1h after mock embryo transfer
|
5 min, 30 min, and 1h after mock embryo transfer
|
Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions
Time Frame: 30 min and 1h post-dosing and on Day OR +5
|
30 min and 1h post-dosing and on Day OR +5
|
Inter-subendometrial space
Time Frame: 5 min, 15 min, 30 min, 1h, 1h 30 min, 2h, 2h 30 min, and 3h after start of dosing, at 5 min, 30 min, and 1h after mock embryo transfer, at 30 min and 1h post-dosing and on Day OR +5
|
5 min, 15 min, 30 min, 1h, 1h 30 min, 2h, 2h 30 min, and 3h after start of dosing, at 5 min, 30 min, and 1h after mock embryo transfer, at 30 min and 1h post-dosing and on Day OR +5
|
Pharmacokinetic parameters of barusiban and atosiban
Time Frame: 2 days after oocyte retrieval (Day OR +2, sampling throughout the day) and 5 days after oocyte retrieval (Day OR +5, one sampling)
|
2 days after oocyte retrieval (Day OR +2, sampling throughout the day) and 5 days after oocyte retrieval (Day OR +5, one sampling)
|
Population pharmacokinetic / pharmacodynamic model
Time Frame: 30 min and 3h after start of dosing
|
30 min and 3h after start of dosing
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FE200440 CS09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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