The Effect of a Liraglutide on IVF in Obese PCOS

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome; Obesity; Infertility, Female

Treatments: Drug: MET; Drug: COMBI

Study type: Interventional

Funder types: Other

Identifiers

NCT03353948

Obese PCOS IVF

Details and patient eligibility

About

The aim of this study was to evaluate the impact of low dose liraglutide in combination with metformin compared to metformin alone on IVF pregnancy rate (PR) and cumulatively PR (IVF and spontaneous) in infertile obese women with PCOS who had been previously poor responders regarding weight reduction with lifestyle modification and resistant to first line reproductive treatments.

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 novel medical therapy (combination of metformin and liraglutide (COMBI)) in the specific infertile obese PCOS population. GLP-1 has been investigated in regulation of reproductive system in animal models. Current observations suggest that it directly regulates kisspeptin and GnRH expression and that ovaries express GLP-1 mRNA. In obese PCOS, GLP-1 receptor agonist liraglutide provided positive effects on weight reduction and glucose homeostasis

Enrollment: 30 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old to 38 years old
• polycystic ovary syndrome (rotterdam criteria)
• BMI of 30 kg/m² or higher
• Infertility
• Before IVF

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 MEN 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 no other ovarian pathology normal male semen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Metfrormin group (MET)

Active Comparator group

Description:

Drug: Metformin

Treatment:

Drug: MET

COMBI group (COMBI)

Active Comparator group

Description:

Drug: liraglutide

Treatment:

Drug: COMBI