Skip to main content
OpenTrials
Completed

NCT Number: NCT05972928

Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

The Study aims to determine the proposed positive influence of Sitagliptin in manipulating hormonal , metabolic and inflammatory parameters in the treatment of Polycystic ovary syndrome and subsequent infertility

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

About this study

Study Design : a Prospective Randomized Controlled Trial.

A Total of 80 infertile Adult Females aged between 18 and 45 years currently diagnosed with Polycystic ovary syndrome , Meeting the Diagnosis of Rotterdam criteria be diagnosed if any two of the following are present: (1) clinical or biochemical hyperandrogenism, (2) evidence of oligo-anovulation, (3) polycystic appearing-ovarian morphology on ultrasound are to be included in the study.

The study will include two groups; each group consists of 40 patients:- Group A : Control Group Group B : Test Group ( will Receive Sitagliptin at a dose of 100 mg every 24 hours

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

polycystic ovary syndrome usually diagnosed based on the Rotterdam criteria if 2 of 3 criteria are present:

  • oligo- and/or anovulation
  • hyperandrogenism (HA) (clinical and/or biochemical)
  • polycystic ovary morphology (PCOM) on ultrasonography (either 12 or more follicles measuring 2-9 mm in diameter and/or an increased ovarian volume >10 cm3).

Exclusion criteria

  • congenital adrenal hyperplasia
  • Brittle control of a thyroid disorder
  • Diabetic on Metformin or any another antidiabetic drugs affecting insulin resistance
  • chronic kidney disease
  • liver dysfunction
  • documented use of oral hormonal contraceptives and hormone-releasing implants in the past 6 months prior to study entry 7.Lipid lowering Consumption

Treatment and study plan

Sitagliptin 100mg

Drug

Sitagliptin at a dose of 100 mg every 24 hours for 3 months

Other names: Januvia 100 mg tab

Primary outcomes

  1. Body weight loss in Kilograms

    Time frame: 3 months

    Body weight before - Body weight after

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effect of Sitagliptin on Clinical, Metabolic and Hormonal Parameters in Polycystic Ovarian Syndrome Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2023
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.