Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05972928
• Other study ID #: Sitagliptin PCO
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 30, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: August 2023
• Source: Beni-Suef University
• Contact: Beni-suef University
• Phone: 082 2318605
• Email: fom[@]med.bsu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

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

1. oligo- and/or anovulation

2. hyperandrogenism (HA) (clinical and/or biochemical)

3. 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:

1. congenital adrenal hyperplasia

2. Brittle control of a thyroid disorder

3. Diabetic on Metformin or any another antidiabetic drugs affecting insulin resistance

4. chronic kidney disease

5. liver dysfunction

6. documented use of oral hormonal contraceptives and hormone-releasing implants in the past 6 months prior to study entry 7.Lipid lowering Consumption

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Beni-suef university Hospital	Bani Suwayf	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight loss in Kilograms	Body weight before - Body weight after	3 months