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

NCT01674283 | Withdrawn Phase 4

• 1 other identifier: OVO-12-08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Women With Fertility Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Embryo implantation and pregnancy rate

  7 weeks

Study Arms (2)

Glucagon

EXPERIMENTAL

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

Sodium chloride 0.9%

PLACEBO COMPARATOR

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

Interventions

Glucagon DRUG

Glucagon

placebo DRUG

Sodium chloride 0.9%

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Interventions

Glucagon

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Eric Himaya, Dr

  clinique ovo and CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: October 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

CA (1)