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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05965908
Other study ID # Liraglutide Polycystic Ovary
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date July 30, 2023
Est. completion date October 30, 2023

Study information

Verified date July 2023
Source Beni-Suef University
Contact Sara A Salem, MD
Phone 01272842226
Email sara_abdallah100@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date October 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
liraglutide
glucagon-like peptide 1 receptor agonist
Metformin
biguanide antihyperglycemic

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 basal body weight - body weight reached after treatment 1 months
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