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Trial Title:
Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients
NCT ID:
NCT05972928
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Sitagliptin Phosphate
Conditions: Keywords:
Polycystic Ovary Syndrome
Sitagliptin
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sitagliptin 100mg
Description:
Sitagliptin at a dose of 100 mg every 24 hours for 3 months
Arm group label:
Sitagliptin
Other name:
Januvia 100 mg tab
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
Detailed 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
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
20 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beni-suef university Hospital
Address:
City:
Banī Suwayf
Zip:
62521
Country:
Egypt
Start date:
July 30, 2023
Completion date:
October 30, 2023
Lead sponsor:
Agency:
Beni-Suef University
Agency class:
Other
Source:
Beni-Suef University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05972928
