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

July 24, 2015 updated by: Clinique Ovo
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Women will have a cycle of in vitro fertilization (IVF) and follow the standard protocol established by the clinic ovo or the fertility clinic of CHUM. On the day of embryo transfer, the investigators will administer 1 mg of Glucagon or placebo intramuscularly 10 minutes before the embryo transfer. The uterine contractility will be measured by ultrasound before and after injection to document the impact of Glucagon on it and we will proceed to embryo transfer.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4P 2S4
        • Clinique OVO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Glucagon
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.
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine muscle relaxation
Time Frame: 30 minutes
Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with a uterine muscle relaxation.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo implantation and pregnancy rate
Time Frame: 7 weeks
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.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Ovo

Investigators

  • Principal Investigator: Eric Himaya, Dr, clinique ovo and CHUM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (ESTIMATE)

August 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 24, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVO-12-08

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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