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Trial · Interventional

CompletedPhase 4Registry data

The Effect of a Liraglutide on IVF in Obese PCOS

NCTNCT03353948 (opens ClinicalTrials.gov in a new tab)Other idObese PCOS IVF
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
30 participants (actual)
Sponsor
University Medical Centre Ljubljana · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
1 Sept 2014
Primary completion
31 May 2016
Completion
1 Sept 2016
First posted
27 Nov 2017
Last update posted
27 Nov 2017
Conditions
Polycystic Ovary Syndrome · Obesity · Infertility, Female

Timeline

1 trial · 1 completed

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

    The Effect of a Liraglutide on IVF in Obese PCOS

    NCT03353948

    1 Sept 2014 to 1 Sept 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 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.

Interventions

  • METDrug
  • COMBIDrug

Arms2

  • Active comparator

    Metfrormin group (MET)

    Drug: Metformin

  • Active comparator

    COMBI group (COMBI)

    Drug: liraglutide

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. IVF pregnancy rates

    Time frame · 14 days

    Registry description

    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. ]

    Registry description

    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

    Registry description

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

Secondary outcomes(2)

  1. Oocyte nuclear maturation

    Time frame · 2 days

    Registry description

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

  2. Embryo quality

    Time frame · 6 days

    Registry description

    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

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)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedSalamun V, Rizzo M, Lovrecic L, Hocevar K, Papler Burnik T, Janez A, Jensterle M, Vrtacnik Bokal E, Peterlin B, Maver A. The Endometrial Transcriptome of Metabolic and Inflammatory Pathways During the Window of Implantation Is Deranged in Infertile Obese Polycystic Ovarian Syndrome Women. Metab Syndr Relat Disord. 2022 Sep;20(7):384-394. doi: 10.1089/met.2021.0149. Epub 2022 Jul 13. PMID 35834645

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 37 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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