The Effect of a Liraglutide on IVF in Obese PCOS

What Was Tested

This registered phase 4 trial tested Liraglutide for pcos.

It had two arms (groups): Metfrormin group (MET) (active comparator) and COMBI group (COMBI) (active comparator).

Drug: Metformin.

Drug: liraglutide.

The registry classes the interventions as drug.

More on the Plan

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in particular when PCOS is linked to obesity.

GLP-1 has been investigated in regulation of reproductive system in animal models.

Who Took Part

30 actual participants took part.

It was open to women only aged from 18 years up to 37 years.

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

Examples of who could join: 18 years old to 38 years old. Polycystic ovary syndrome (rotterdam criteria). BMI of 30 kg/m² or higher.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: type 1 or type 2 diabetes mellitus; history of carcinoma; cushing's syndrome or congenital (non-classic) adrenal hyperplasia.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the pcos participants stayed in one arm throughout.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-09-01 with completion listed for 2016-05-31.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: IVF pregnancy rates (time frame: 14 days). BMI (time frame: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial. ]). Cumulative pregnancy rates (time frame: The pregnancies were collected by phone interview after one year).

It also tracked 2 secondary outcomes, for example Oocyte nuclear maturation and Embryo quality.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 30 people with pcos.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, PCOS research.