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

NCT03034941 | Completed Phase 4

• 1 other identifier: Obesity,PCOS and IVF
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; PCOS

Keywords

Obesity; PCOS; Infertility; Liraglutide; Metformin; IVF

Outcome Measures

Primary Outcomes (1)

• The main outcome was change in BMI

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (3)

metformin group

ACTIVE COMPARATOR

Drug: metformin

Drug: Metformin

COMBI group

ACTIVE COMPARATOR

Drug: liraglutide + metformin

Drug: Metformin; Drug: Liraglutide + metformin

CONTROL group

NO INTERVENTION

control group of obese PCOS patients without therapy

Interventions

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

Also known as: Glucophage tablets

COMBI group; metformin group

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.

Also known as: Victoza 6 mg/ml solution and Glucophage tablets

COMBI group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• polycystic ovary syndrome (rotterdam criteria)
• BMI of 30 kg/m² or higher
• Infertility for IVF with normal male sperm

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Location

Related Publications (3)

• Jensterle Sever M, Kocjan T, Pfeifer M, Kravos NA, Janez A. Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin. Eur J Endocrinol. 2014 Feb 7;170(3):451-9. doi: 10.1530/EJE-13-0797. Print 2014 Mar.

  PMID: 24362411 BACKGROUND

• Jungheim ES, Lanzendorf SE, Odem RR, Moley KH, Chang AS, Ratts VS. Morbid obesity is associated with lower clinical pregnancy rates after in vitro fertilization in women with polycystic ovary syndrome. Fertil Steril. 2009 Jul;92(1):256-61. doi: 10.1016/j.fertnstert.2008.04.063. Epub 2008 Aug 9.

  PMID: 18692801 BACKGROUND

• Depalo R, Garruti G, Totaro I, Panzarino M, Vacca MP, Giorgino F, Selvaggi LE. Oocyte morphological abnormalities in overweight women undergoing in vitro fertilization cycles. Gynecol Endocrinol. 2011 Nov;27(11):880-4. doi: 10.3109/09513590.2011.569600. Epub 2011 Apr 18.

  PMID: 21500991 BACKGROUND

MeSH Terms

Conditions

Obesity; Infertility

Interventions

Metformin; Liraglutide; Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmaceutical Preparations

Study Officials

• Eda Vrtacnik Bokal, professor

  University Medical Centre Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, MD, PhD

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 27, 2017
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

SL (1)