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

January 25, 2017 updated by: Andrej Janez, University Medical Centre Ljubljana

Short Term Weight Loss With Liraglutide and Metformin Before IVF 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia
        • University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: metformin group
Drug: metformin
Drug: Metformin
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
Active Comparator: COMBI group
Drug: liraglutide + metformin
Drug: Metformin
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
Drug: Liraglutide + metformin
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
No Intervention: CONTROL group
control group of obese PCOS patients without therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: patients were introduced to IVF one month after completed weight loss therapy
patients were introduced to IVF one month after completed weight loss therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Chair: Eda Vrtacnik Bokal, professor, University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obesity,PCOS and IVF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data are going to be available for other researchers if needed after the evaluation of this study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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