The Effect of a Liraglutide on IVF in Obese PCOS

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Obesity; Infertility, Female
• Interventions: Drug: MET; Drug: COMBI

• Registration Number: NCT03353948
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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.

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 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

Study Timeline

• Study Start: 2014-09-01
• Primary Completion: 2016-05-31
• Study Completion: 2016-09-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Study First Posted: 2017-11-27
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metfrormin group (MET)	MET	Drug: Metformin
COMBI group (COMBI)	COMBI	Drug: liraglutide

Primary Outcome Measures

Name	Time	Method
IVF pregnancy rates	14 days	Clinical pregnancy rate defined as the presence of a fetal heart beat by ultrasound
BMI	Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial. ]	Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
Cumulative pregnancy rates	The pregnancies were collected by phone interview after one year	Number of all pregnancies (IVF pregnancies and spontaneous pregnancies) per patient

Secondary Outcome Measures

Name	Time	Method
Oocyte nuclear maturation	2 days	The number of metaphase 2 oocytes, metaphase 1 oocytes, and germinal vesicles
Embryo quality	6 days	The embryo quality assessed by standard cleavage stage embryo grading system on day 3 of embryo culture. For any embryos grown to day 5, the embryo quality assessed by standard blastocyst grading system on day 5 of embryo culture