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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT03034941 (opens ClinicalTrials.gov in a new tab)Other idObesity,PCOS and IVF
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
35 participants (actual)
Sponsor
University Medical Centre Ljubljana · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Slovenia

Start
Apr 2014
Primary completion
Dec 2016
Completion
Dec 2016
First posted
27 Jan 2017 (estimated)
Last update posted
27 Jan 2017 (estimated)
Conditions
Obesity · PCOS

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 4

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

    NCT03034941

    Apr 2014 to Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • MetforminDrug
  • Liraglutide + metforminDrug

Arms3

  • Active comparator

    metformin group

    Drug: metformin

  • Active comparator

    COMBI group

    Drug: liraglutide + metformin

  • No intervention

    CONTROL group

    control group of obese PCOS patients without therapy

Primary outcomes1

Outcomes the sponsor listed as primary.

  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(2)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

15 results

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.

Jensterle Sever et al. 2014European journal of endocrinologycited by 124

PMID 24362411PMC3922503DOI 10.1530/eje-13-0797PUB-24362411

CC BY15 results
Download PDFSee results (15)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 38 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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