Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

Beni-Suef University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Sitagliptin 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05972928

Sitagliptin PCO

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Sitagliptin

Experimental group

Description:

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

Treatment:

Drug: Sitagliptin 100mg

control

No Intervention group

Description:

patient won't receive medication