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

NCT ID: NCT01674283

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-10-31

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.

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.

Conditions

Women With Fertility Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Glucagon

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Glucagon

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinique Ovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Himaya, Dr

Role: PRINCIPAL_INVESTIGATOR

clinique ovo and CHUM

Locations

Clinique Ovo

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

OVO-12-08

Identifier Type: -

Identifier Source: org_study_id