Comparing the Effect of Sitagliptin/Metformin and Metformin in PCOS Patients

Study Overview
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Brief Summary
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Investigators will evaluate and compare the efficacy of Sitagliptin/Metformin to metformin and sitagliptin on gdf9 and bmp15 gene expression on PCOS patients undergoing intracytoplasmic sperm injection(ICSI).

Detailed Description
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This study was conducted in Infertility clinic of Mahdiyeh Educational Hospital, Tehran. Patients in the four groups receive the drug 2 months before the start of the ovulation cycle, and treatment will continue until the day of the oocyte aspiration. The drug provide by midwife to patients and both patient and physician blind to the treatment regimen. The participants randomly divide into four groups.The ovulation induction stimulate with GnRh antagonist.

Official Title
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Comparing the Therapeutic Effect of Sitagliptin/Metformin and Metformin on Biochemical Factors and Expression of GDF-9 and BMP-15 Genes in Patients With Classic PCOS Undergoing Intra-cytoplasmic Sperm Injection (ICSI)

Conditions
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Polycystic Ovary Syndrome, Infertility, ART

Intervention / Treatment
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* Drug: placebo
* Drug: metformin
* Drug: Sitagliptin
* Drug: Sitagliptin/metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject has clinical or biochemical hyperandrogenic symptoms subject has oligo/amenorrhea cycles Exclusion Criteria: Hypersensitivity to metformin Hypersensitivity to sitagliptin presence of infertility factors other than anovulation, male infertility pelvic organic pathologies congenital adrenal hyperplasia thyroid dysfunction Cushing's syndrome hyper prolactinemia androgen secreting neoplasia diabetes mellitus consumption of medications affecting carbohydrate metabolism consumption hormonal analogues other than progesterone 2 months prior to enrolment in the study severe hepatic pancreatitis kidney diseases gallbladder diseases

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily | Drug: placebo<br>* Oral rehydration solution<br>* Other names: rehydration solution;|
| Experimental: Metformin<br>Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily | Drug: metformin<br>* metformin tablet<br>* Other names: Glucophage;|
| Experimental: Sitagliptin<br>Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily | Drug: Sitagliptin<br>* Sitagliptin tablet<br>* Other names: JANUVIA;|
| Experimental: sitagliptin/metformin<br>Intervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily | Drug: Sitagliptin/metformin<br>* Sitagliptin/metformin tablet<br>* Other names: JANUMET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting insulin | ELIZA hormone assay | 24 hours after last dose | 
| Growth differentiation factor-9(GDF-9) expression | Realtime PCR | 24 hours after last dose | 
| Bone morphogenetic protein-15(BMP-15) expression | Realtime PCR | 24 hours after last dose | 
| Total Testosterone | ELIZA hormone assay | 24 hours after last dose | 
| Follicle-stimulating hormone(FSH) | ELIZA hormone assay | 24 hours after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metformin, sitagliptin, Polycystic Ovary Syndrome, Intracytoplastic sperm injection