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

Phase 4

Completed

• Conditions: PCOS; Obesity
• Interventions: Drug: Metformin; Drug: Liraglutide + metformin

• Registration Number: NCT03034941
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2014-04
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-25
• Last Update Submitted: 2017-01-25
• Study First Posted: 2017-01-27
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COMBI group	Liraglutide + metformin	Drug: liraglutide + metformin
metformin group	Metformin	Drug: metformin
COMBI group	Metformin	Drug: liraglutide + metformin

Primary Outcome Measures

Name	Time	Method
The main outcome was change in BMI	Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial.

Secondary Outcome Measures

Name	Time	Method
Impact of the short term weight loss 5% or more before IVF on oocyte maturity in infertile obese PCOS population.	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.	patients were introduced to IVF one month after completed weight loss therapy

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia