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Completed

NCT Number: NCT03034941

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

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.

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Key information

Conditions

Obesity Body Weight Genital Diseases Infertility Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight PCOS Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Ljubljana

Ljubljana, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

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

Other names: Glucophage tablets

Liraglutide + metformin

Drug

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.

Other names: Victoza 6 mg/ml solution and Glucophage tablets

Primary outcomes

  1. The main outcome was change in BMI

    Time frame: Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial.

Secondary outcomes

  1. Impact of the short term weight loss 5% or more before IVF on oocyte maturity in infertile obese PCOS population.

    Time frame: patients were introduced to IVF one month after completed weight loss therapy

  2. Impact of the short term weight loss 5% or more before IVF on oocyte number of blastocysts in infertile obese PCOS population.

    Time frame: patients were introduced to IVF one month after completed weight loss therapy

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 27, 2017
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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