Trial intelligence / Profile preview

Sitagliptin and Metformin in PCOS Patients Undergoing ICSI

NCT04268563Phase 2

Key facts

Status: Unknown
Start: Jan 2020
Primary completion: Jul 2021
Countries: 1
Sponsor: Shahid Beheshti University of Medical Sciences
Modality: Small Molecules

Drugs: sitagliptin
Conditions: polycystic ovary syndrome (PCOS)infertility

Overview

Phase 2, randomised, double-blind trial of sitagliptin in polycystic ovary syndrome (PCOS) and infertility (4 arms), sponsored by Shahid Beheshti University of Medical Sciences. Primary endpoints: Fasting insulin, Growth differentiation factor-9 expression and 3 more. Status: unknown.

Design

4 arms

Study design: RandomizedDouble-blind

Placebo
Oral rehydration salts
Metformin
Metformin 500 mg bid
Sitagliptin
Sitagliptin 50 mg bid
Sitagliptin/Metformin
Sitagliptin 50 mg / Metformin 500 mg bid

Who it enrols

Women with classic PCOS and infertility undergoing ICSI, excluding those with diabetes, thyroid dysfunction, or other infertility factors.

Endpoints

Primary

Fasting insulin24 hours after last dose
Growth differentiation factor-9 expression24 hours after last dose
Bone morphogenetic protein-15 expression24 hours after last dose
Total Testosterone24 hours after last dose
Follicle-stimulating hormone24 hours after last dose

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