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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short Term Weight Loss With Liraglutide and Metformin Before IVF in Infertile Obese PCOS Patients

Conditions
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Obesity, PCOS

Intervention / Treatment
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* Drug: Metformin
* Drug: Liraglutide + metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: metformin group<br>Drug: metformin | Drug: Metformin<br>* 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<br>* Other names: Glucophage tablets;|
| Active Comparator: COMBI group<br>Drug: liraglutide + metformin | Drug: Metformin<br>* 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<br>* Other names: Glucophage tablets;Drug: Liraglutide + metformin<br>* 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.<br>* Other names: Victoza 6 mg/ml solution and Glucophage tablets;|
| No Intervention: CONTROL group<br>control group of obese PCOS patients without therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformin, IVF, Obesity, PCOS, Infertility, Liraglutide