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

This study has been withdrawn prior to enrollment.
(Uterine contractility not possible to visualize with our ultrasound machines)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01674283
First Posted: August 28, 2012
Last Update Posted: July 28, 2015
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):
OVO R & D
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]
    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 ]
    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.


Enrollment: 0
Study Start Date: October 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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): NCT01674283


Locations
Canada, Quebec
Clinique Ovo
Montréal, Quebec, Canada, H4P 2S4
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Eric Himaya, Dr clinique ovo and CHUM
  More Information

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01674283     History of Changes
Other Study ID Numbers: OVO-12-08
First Submitted: August 23, 2012
First Posted: August 28, 2012
Last Update Posted: July 28, 2015
Last Verified: July 2015

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