Obesity, PCOS
Conditions
Keywords
Obesity, PCOS, Infertility, Liraglutide, Metformin, IVF
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.
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.
Interventions
DRUGMetformin
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
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.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome was change in BMI | Patient's BMI was measured at the beginning and every four weeks during 12 weeks of clinical trial. |
Secondary
| Measure | Time frame |
|---|---|
| Impact of the short term weight loss 5% or more before IVF on oocyte maturity in infertile obese PCOS population. | 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. | patients were introduced to IVF one month after completed weight loss therapy |
Countries
Slovenia
Outcome results
None listed