Short Term Weight Loss With Liraglutide and Metformin in Infertile Obese PCOS Patients

University Medical Centre Ljubljana35 enrolled

Overview

The aim of this study was to evaluate the impact of short-term weight reduction achieved with 12-week intervention with metformin alone or in combination with liraglutide on oocyte maturity and embryo quality in infertile obese PCOS population.

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility, in particular when PCOS is linked to obesity. Obese PCOS has poor IVF outcomes associated with impaired oocyte and embryo parameters and morphology. The purpose of this pilot prospective study was to investigate the effect of the antiobesity medical therapy (combination of metformin and liraglutide (COMBI)) on short time weight loss in the specific infertile obese PCOS population. Additionally, we analyzed eventual impact of the short term weight loss 5% or more before IVF on oocyte maturity and embryo quality in infertile obese PCOS population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity PCOS

Interventions

MetforminDRUG

In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg twice per day per os for 12 weeks

Liraglutide + metforminDRUG

In the COMBI group the initial dose of metformin was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg twice per day. Liraglutide 1.2 mg once per day s.c. was added after first two weeks of monotherapy with metformin.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 38 Years

Medical Language ↔ Plain English

Inclusion Criteria: * polycystic ovary syndrome (rotterdam criteria) * BMI of 30 kg/m² or higher * Infertility for IVF with normal male sperm Exclusion Criteria: * type 1 or type 2 diabetes mellitus * history of carcinoma * Cushing's syndrome or congenital (non-classic) adrenal hyperplasia * personal or family history of multiple endocrine neoplasia 2 * significant cardiovascular, kidney or hepatic disease * the use of medications known or suspected to affect reproductive or metabolic functions * the use of statins, within 90 days prior to study entry

Locations (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

The main outcome was change in BMI

Time frame: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial.

Secondary Outcomes

Impact of the short term weight loss 5% or more before IVF on oocyte maturity in infertile obese PCOS population.

Time frame: patients were introduced to IVF one month after completed weight loss therapy

Impact of the short term weight loss 5% or more before IVF on oocyte number of blastocysts in infertile obese PCOS population.

Time frame: patients were introduced to IVF one month after completed weight loss therapy

Data from ClinicalTrials.gov

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