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

Plain-language guide to NCT01674283: phase 4 randomized trial of Glucagon. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01674283
Phase
phase 4
Status
withdrawn
Start
2013-10
Completion (planned or actual)
2013-10
Participants
n/a (actual)
Design
randomized, single-blind, treatment
Conditions studied
Women With Fertility Disorder
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Glucagon.

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 had two arms (groups): Glucagon (experimental) and one (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 Glucagon. The second recording is doing the same way 10 minutes after the Glucagon injection, just before the embryo transfer.

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.

The registry classes the interventions as drug.

More on the Plan

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.

The uterine contractility will be measured by ultrasound before and after injection to document the impact of Glucagon on it and the researchers will proceed to embryo transfer.

Who Took Part

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: body mass index \> 35 kg/m2; women with diabetes; women with hypertensive disorders.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

The Glucagon group and the comparison group ran side by side rather than switching.

In this single-blind Glucagon study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2013-10 with completion listed for 2013-10.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Uterine muscle relaxation (time frame: 30 minutes).

It also tracked 1 secondary outcome, for example Embryo implantation and pregnancy rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glucagon in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page, all human trials.

Our Notes on the Compound

Glucagon: A 29-amino-acid pancreatic hormone that raises blood glucose; used as a rescue medicine for severe low blood sugar and as a diagnostic aid.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.