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

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: PCOS; Obesity

Treatments: Drug: Metformin; Drug: Liraglutide + metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03034941

Obesity,PCOS and IVF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

metformin group

Active Comparator group

Description:

Drug: metformin

Treatment:

Drug: Metformin

COMBI group

Active Comparator group

Description:

Drug: liraglutide + metformin

Treatment:

Drug: Liraglutide + metformin

Drug: Metformin

CONTROL group

No Intervention group

Description:

control group of obese PCOS patients without therapy