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

Sponsor
University Medical Centre Ljubljana
Study ID
NCT03034941
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 38 Years
Healthy Volunteers
Not accepted

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
  • 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2014
Status verified
Dec 2016
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
35 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

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. ]

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