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Completed

NCT Number: NCT03353948

The Effect of a Liraglutide on IVF in Obese PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Infertility, Female Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

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 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MET

Drug

In the MET 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 BID per os for 12 weeks. After 1 month IVF was done.

Other names: Glucophage tbl

COMBI

Drug

In the COMBI group the initial dose of MET was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg BID. Liraglutide 1.2 mg QD s.c. was added after first two weeks of monotherapy with MET. After 1 month IVF was done.

Other names: Victoza 6 mg/ml solution for injection in pre-filled pen

Primary outcomes

  1. IVF pregnancy rates

    Time frame: 14 days

    Clinical pregnancy rate defined as the presence of a fetal heart beat by ultrasound

  2. BMI

    Time frame: 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.

  3. Cumulative pregnancy rates

    Time frame: The pregnancies were collected by phone interview after one year

    Number of all pregnancies (IVF pregnancies and spontaneous pregnancies) per patient

Secondary outcomes

  1. Oocyte nuclear maturation

    Time frame: 2 days

    The number of metaphase 2 oocytes, metaphase 1 oocytes, and germinal vesicles

  2. Embryo quality

    Time frame: 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

Other outcomes

  1. The other outcomes was changes changes in fasting concentrations of glucose

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

    Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.

  2. The other outcomes was changes changes in fasting concentrations of insulin

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

    Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.

  3. Other outcome was change in blood concentration of testosterone

    Time frame: Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial. ]

    Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L.

  4. Other outcome was change in blood concentration in androstenedione.

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

    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L.

  5. Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin).

    Time frame: Patient's fasting blood was drawn at the beginning and every four weeks during the 12 weeks of clinical trial. ]

    Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

The Effect of Liraglutide on Pregnancy Rates in Obese Women With PCOS Undergoing in Vitro Fertilization: a Pilot Randomized Study

Important dates

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