Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

Study Overview
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Brief Summary
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The Study aims to determine the proposed positive influence of Sitagliptin in manipulating hormonal , metabolic and inflammatory parameters in the treatment of Polycystic ovary syndrome and subsequent infertility

Detailed Description
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Study Design : a Prospective Randomized Controlled Trial. A Total of 80 infertile Adult Females aged between 18 and 45 years currently diagnosed with Polycystic ovary syndrome , Meeting the Diagnosis of Rotterdam criteria be diagnosed if any two of the following are present: (1) clinical or biochemical hyperandrogenism, (2) evidence of oligo-anovulation, (3) polycystic appearing-ovarian morphology on ultrasound are to be included in the study. The study will include two groups; each group consists of 40 patients:- Group A : Control Group Group B : Test Group ( will Receive Sitagliptin at a dose of 100 mg every 24 hours

Official Title
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Effect of Sitagliptin on Clinical, Metabolic and Hormonal Parameters in Polycystic Ovarian Syndrome Patients

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Sitagliptin 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: polycystic ovary syndrome usually diagnosed based on the Rotterdam criteria if 2 of 3 criteria are present: oligo- and/or anovulation hyperandrogenism (HA) (clinical and/or biochemical) polycystic ovary morphology (PCOM) on ultrasonography (either 12 or more follicles measuring 2-9 mm in diameter and/or an increased ovarian volume >10 cm3). Exclusion Criteria: congenital adrenal hyperplasia Brittle control of a thyroid disorder Diabetic on Metformin or any another antidiabetic drugs affecting insulin resistance chronic kidney disease liver dysfunction documented use of oral hormonal contraceptives and hormone-releasing implants in the past 6 months prior to study entry 7.Lipid lowering Consumption

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: Sitagliptin<br>Sitagliptin at a dose of 100 mg every 24 hours for 3 months | Drug: Sitagliptin 100mg<br>* Sitagliptin at a dose of 100 mg every 24 hours for 3 months<br>* Other names: Januvia 100 mg tab;|
| No Intervention: control<br>patient won't receive medication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight loss in Kilograms | Body weight before - Body weight after | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Sitagliptin