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Trial Title:
Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome
NCT ID:
NCT05965908
Condition:
Polycystic Ovary
Conditions: Official terms:
Polycystic Ovary Syndrome
Metformin
Liraglutide
Conditions: Keywords:
polycystic ovary
liraglutide
Study type:
Interventional
Study phase:
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:
liraglutide
Description:
glucagon-like peptide 1 receptor agonist
Arm group label:
liraglutide
Other name:
saxenda ampoules
Intervention type:
Drug
Intervention name:
Metformin
Description:
biguanide antihyperglycemic
Arm group label:
metformin
Other name:
Glucophage 1000mg
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
Criteria for eligibility:
Criteria:
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
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/NCT05965908
