Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

Phase 3

Not yet recruiting

• Conditions: Polycystic Ovary
• Interventions: Drug: liraglutide; Drug: Metformin

• Registration Number: NCT05965908
• Lead Sponsor: Beni-Suef University

Brief Summary

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

Detailed Description

It is a Prospective randomized controlled trial .The study will include 80 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), The study will include two groups; each group consists of 40 patients:-

* Group1 (n=40) will be treated by liraglutide monotherapy.

* Group 2 (n=40) will be treated by metformin monotherapy.

* Group 3 (n=40) will be a control group.

To assess the metabolic effect of each treatment, the following parameters will be assessed before and after the treatment

* To assess the hormonal effect of each treatment, the following tests will be assessed before and after treatment

* Total Testosterone (TT)

* Dehydroepiandrosterone (DHEA)

To assess the clinical effect of the drugs, the following will be assessed before and after treatment:

The number of medium size follicles and large size follicles and the endometrium thickness were assessed on the tenth or eleventh day of menstruation. The chemical and clinical pregnancy rates were evaluated

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-07-28
• Last Update Submitted: 2023-07-28
• Study Start: 2023-07-30
• Last Update Posted: 2023-08-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• aged between 20 and 45 years
• PCO

Exclusion Criteria

1. congenital adrenal hyperplasia
2. poorly controlled thyroid disease
3. Taking antidiabetic drugs which can affect insulin resistance
4. chronic kidney disease and history of recurrent urinary tract infections
5. liver dysfunction
6. documented use of oral hormonal contraceptives and hormone-releasing implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liraglutide	liraglutide	Saxenda® starting dose is 0.6 mg per day for 1 week.1. Patients increase the dose by 0.6 mg each week until the full maintenance dose of 3 mg is reached
metformin	Metformin	the patient is given Glucophage 1000 mg tab once daily after lunch for 1month

Primary Outcome Measures

Name	Time	Method
Body weight loss	1 months	basal body weight - body weight reached after treatment

Trial Locations

Locations (1)

Beni-suef university Hospital; 🇪🇬 Banī Suwayf, Beni Suef, Egypt