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

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome; Infertility; ART
• Intervention / Treatment: Drug: placebo; Drug: metformin; Drug: Sitagliptin; Drug: Sitagliptin/metformin

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Delbar Daneshjou, PHD student; Phone Number: 989120823342; Email: db.daneshjou@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1989930002
    • Recruiting
    • Mahdiyeh educational hospital
    • Contact: Delbar Daneshjou, PHD student; Phone Number: 989120823342; Email: db.daneshjou@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Study Director: Shahrzad Shahrzad Zadehmodarres, Professor, Shahid Beheshti University of Medical Sciences

Publications and helpful links

General Publications

• Daneshjou D, Zadeh Modarres S, Soleimani Mehranjani M, Shariat Zadeh SMA. Comparing the effect of sitagliptin and metformin on the oocyte and embryo quality in classic PCOS patients undergoing ICSI. Ir J Med Sci. 2021 May;190(2):685-692. doi: 10.1007/s11845-020-02320-5. Epub 2020 Jul 28.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Anticipated): July 19, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Polycystic Ovary Syndrome; metformin; sitagliptin; Intracytoplastic sperm injection
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Infertility; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate
• Other Study ID Numbers: 11367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No