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Trial · Interventional

WithdrawnPhase 4Registry data

Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization

Overview

Status
Withdrawn
Phase
Phase 4
Enrollment
0 participants (actual)
Sponsor
Clinique Ovo · Industry
Design
Randomized · Single masking
Countries
1 country

Canada

Start
Oct 2013
Primary completion
Oct 2013
Completion
Oct 2013
First posted
28 Aug 2012 (estimated)
Last update posted
28 Jul 2015 (estimated)
Conditions
Women With Fertility Disorder

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014
  1. Ph 4

    Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization

    NCT01674283

    Oct 2013 to Oct 2013

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The success of in vitro fertilization is based mainly on uterine implantation embryo. An excessive uterine contractility may interfere with implantation by a movement of the embryo in the uterus. The inhibition of the uterine contractility may have a positive effect on success rate of in vitro fertilization. It is through parenteral injection of glucagon and its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the time of embryo transfer, the investigators intend to improve the pregnancy rates obtained after IVF.

Interventions

  • GlucagonDrug
  • placeboDrug

Arms2

  • Experimental

    Glucagon

    The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of Glucagon. The second recording is doing the same way 10 minutes after the Glucagon injection, just before the embryo transfer.

  • Placebo comparator

    Sodium chloride 0.9%

    The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of the placebo. The second recording is doing the same way 10 minutes after the placebo injection, just before the embryo transfer.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Uterine muscle relaxation

    Time frame · 30 minutes

    Registry description

    Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with a uterine muscle relaxation.

Secondary outcomes(1)
  1. Embryo implantation and pregnancy rate

    Time frame · 7 weeks

    Registry description

    Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with higher implantation and pregnancy rates than during embryo transfer without glucagon.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Women doing fertility treatment at the clinic ovo or fertility clinic of CHUM * Less than 40 years old * Women with stimulate in vitro fertilization cycle * Women able to give her consent Exclusion Criteria: * Body mass index \> 35 kg/m2 * Women with diabetes * Women with hypertensive disorders * Women with a blood pressure greater or equal to 140/90 mmHg at the randomization visit * Cons-indication to taking Glucagon: * Hypersensitivity to product * Pheochromocytoma or history of pheochromocytoma * Insulinoma * Taking a beta-blocker (drug interactions)

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