NCT03034941

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• PCOS

Interventions

Type	Name	Description
DRUG	Metformin	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
DRUG	Liraglutide + metformin	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.

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2017-01-27
• Last updated: 2017-01-27

Locations

1 site across 1 country: Slovenia