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

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ClinicalTrials.gov Identifier: NCT03034941
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Obesity PCOS Drug: Metformin Drug: Liraglutide + metformin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Term Weight Loss With Liraglutide and Metformin Before IVF in Infertile Obese PCOS Patients
Study Start Date : April 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Victoza 6 mg/ml solution and Glucophage tablets

No Intervention: CONTROL group
control group of obese PCOS patients without therapy



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034941


Locations
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Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Study Chair: Eda Vrtacnik Bokal, professor University Medical Centre Ljubljana

Publications:
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Responsible Party: Andrej Janez, professor, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03034941     History of Changes
Other Study ID Numbers: Obesity,PCOS and IVF
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data are going to be available for other researchers if needed after the evaluation of this study.

Keywords provided by Andrej Janez, University Medical Centre Ljubljana:
Obesity
PCOS
Infertility
Liraglutide
Metformin
IVF

Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Metformin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists