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

Women With Fertility Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01674283
• Other study ID #: OVO-12-08
• Status: Withdrawn
• Phase: Phase 4
• First received: August 23, 2012
• Last updated: July 24, 2015
• Start date: October 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2015
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Women With Fertility Disorder

Intervention

Drug:
• Glucagon

• placebo

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
OVO R & D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine muscle relaxation	Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with a uterine muscle relaxation.	30 minutes	No
Secondary	Embryo implantation and pregnancy rate	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	No