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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Infertility; Polycystic Ovary Syndrome; ART

Treatments: Drug: placebo; Drug: metformin; Drug: Sitagliptin; Drug: Sitagliptin/metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04268563

11367

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily

Treatment:

Drug: placebo

Metformin

Experimental group

Description:

Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily

Treatment:

Drug: metformin

Sitagliptin

Experimental group

Description:

Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily

Treatment:

Drug: Sitagliptin

sitagliptin/metformin

Experimental group

Description:

Intervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily

Treatment:

Drug: Sitagliptin/metformin