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

This study is not yet open for participant recruitment.
Verified June 2013 by OVO R & D
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01674283
First received: August 23, 2012
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Women With Fertility Disorder
Drug: Glucagon
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization

Resource links provided by NLM:


Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Uterine muscle relaxation [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with a uterine muscle relaxation.


Secondary Outcome Measures:
  • Embryo implantation and pregnancy rate [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674283

Contacts
Contact: Kécelle Viaud, RN (514) 798-2000 ext 759 k.viaud@cliniqueovo.com
Contact: Sophie Leblanc, RN 514-798-2000 ext 617 s.leblanc@cliniqueovo.com

Locations
Canada, Quebec
Clinique Ovo Not yet recruiting
Montréal, Quebec, Canada, H4P 2S4
Contact: Shirley Brugerie, Director         
Contact: Kécelle Viaud, RN    514-798-2000 ext 759    s.leblanc@cliniqueovo.com   
Principal Investigator: Himaya Eric, MD         
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Eric Himaya, Dr clinique ovo and CHUM
  More Information

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01674283     History of Changes
Other Study ID Numbers: OVO-12-08
Study First Received: August 23, 2012
Last Updated: June 21, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Glucagon
Glucagon-Like Peptide 1
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins

ClinicalTrials.gov processed this record on April 17, 2014