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

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04268563

Collaborator

(none)

Enrollment

Location

Arms

18.6

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Infertility ART	Drug: placebo Drug: metformin Drug: Sitagliptin Drug: Sitagliptin/metformin	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Jan 10, 2020

Anticipated Primary Completion Date :

Jul 19, 2021

Anticipated Study Completion Date :

Jul 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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