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

Sponsor

Clinique Ovo (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01674283

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Women With Fertility Disorder	Drug: Glucagon Drug: placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Uterine muscle relaxation [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Clinique Ovo	Montréal	Quebec	Canada	H4P 2S4

Sponsors and Collaborators

Clinique Ovo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clinique Ovo

ClinicalTrials.gov Identifier:

NCT01674283

Other Study ID Numbers:

OVO-12-08

First Posted:

Aug 28, 2012

Last Update Posted:

Jul 28, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Glucagon

Study Results

No Results Posted as of Jul 28, 2015