Effect of Sitagliptin on Polycystic Ovarian Syndrome Patients

NCT ID: NCT05972928

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-30

Study Completion Date

2023-10-30

Brief Summary

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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

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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

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sitagliptin

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

Group Type EXPERIMENTAL

Sitagliptin 100mg

Intervention Type DRUG

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

control

patient won't receive medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sitagliptin 100mg

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

Intervention Type DRUG

Other Intervention Names

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Januvia 100 mg tab

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Beni-suef University

Role: CONTACT

082 2318605 ext. 02

Other Identifiers

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Sitagliptin PCO

Identifier Type: -

Identifier Source: org_study_id

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