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

Phase 1

• Conditions: Infertility; ART; Polycystic Ovary Syndrome
• Interventions: Drug: placebo; Drug: Sitagliptin/metformin; Drug: metformin; Drug: Sitagliptin

• Registration Number: NCT04268563
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-10
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-22
• Primary Completion: 2021-07-19
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• subject has clinical or biochemical hyperandrogenic symptoms
• subject has oligo/amenorrhea cycles

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily
sitagliptin/metformin	Sitagliptin/metformin	Intervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily
Metformin	metformin	Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily
Sitagliptin	Sitagliptin	Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mahdiyeh educational hospital; 🇮🇷 Tehran, Iran, Islamic Republic of