Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

Detailed Description
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It is a Prospective randomized controlled trial .The study will include 80 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), The study will include two groups; each group consists of 40 patients:- Group1 (n=40) will be treated by liraglutide monotherapy. Group 2 (n=40) will be treated by metformin monotherapy. Group 3 (n=40) will be a control group. To assess the metabolic effect of each treatment, the following parameters will be assessed before and after the treatment To assess the hormonal effect of each treatment, the following tests will be assessed before and after treatment Total Testosterone (TT) Dehydroepiandrosterone (DHEA) To assess the clinical effect of the drugs, the following will be assessed before and after treatment: The number of medium size follicles and large size follicles and the endometrium thickness were assessed on the tenth or eleventh day of menstruation. The chemical and clinical pregnancy rates were evaluated

Official Title
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Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary

Intervention / Treatment
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* Drug: liraglutide
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 20 and 45 years PCO Exclusion Criteria: congenital adrenal hyperplasia poorly controlled thyroid disease Taking antidiabetic drugs which can affect insulin resistance chronic kidney disease and history of recurrent urinary tract infections liver dysfunction documented use of oral hormonal contraceptives and hormone-releasing implants

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Experimental: liraglutide<br>Saxenda® starting dose is 0.6 mg per day for 1 week.1. Patients increase the dose by 0.6 mg each week until the full maintenance dose of 3 mg is reached | Drug: liraglutide<br>* glucagon-like peptide 1 receptor agonist<br>* Other names: saxenda ampoules;|
| Active Comparator: metformin<br>the patient is given Glucophage 1000 mg tab once daily after lunch for 1month | Drug: Metformin<br>* biguanide antihyperglycemic<br>* Other names: Glucophage 1000mg;|
| No Intervention: control<br>not given any drug | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight loss | basal body weight - body weight reached after treatment | 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary, liraglutide