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Effect of Oxytocin Antagonist on Reduction of Uterine Contractions (EFFORT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01043120
First Posted: January 6, 2010
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  Purpose
The main purpose of this clinical research trial was to evaluate the effects of barusiban compared to placebo on uterine contractions on luteal phase uterine contractions in oocyte donors supplemented with progesterone.

Condition Intervention Phase
In Vitro Fertilisation (IVF) Treatment Drug: Barusiban Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

Enrollment: 99
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Barusiban Drug: Barusiban
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 Drug: 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.

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  Eligibility

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Participants eligible for this trial were oocyte donors 18-37 years of age, who had undergone controlled ovarian hyperstimulation in the long GnRH agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, had received hCG (10,000 IU urinary hCG or 250 μg recombinant hCG) for triggering of final follicular maturation and had undergone oocyte retrieval. Participants had given signed informed consent, were generally healthy and with a body mass index (BMI) of 18.5-29 kg/m2.

Participants were excluded in case of endometriosis stage I-IV or uterine pathology. Participants were willing to not have intake of alcoholic beverages during the trial, to not have sexual intercourse during the trial, and to either maintain sexual abstinence or use a highly effective method of contraception from end-of-trial till onset of next menses.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043120


Locations
Belgium
UZ Brussel
Brussels, Belgium
Czechia
IVF Institute
Plzen, Czechia
ISCARE IVF a.s.
Prague, Czechia
Spain
IU Dexeus
Barcelona, Spain
IVI Madrid
Madrid, Spain
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01043120     History of Changes
Other Study ID Numbers: FE200440 CS11
2009-012323-29
First Submitted: January 5, 2010
First Posted: January 6, 2010
Last Update Posted: June 21, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs