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NCT Number: NCT05965908

Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

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

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Key information

Conditions

Polycystic Ovary Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

About this study

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=50) will be treated by liraglutide monotherapy.
  • Group 2 (n=50) will be treated by metformin monotherapy.
  • Group 3 (n=50) 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 ovulation was assessed on the tenth or eleventh day of menstruation. The chemical and clinical pregnancy rates were evaluated

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 20 and 45 years
  • PCO

Exclusion criteria

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

Treatment and study plan

liraglutide

Drug

glucagon-like peptide 1 receptor agonist

Other names: saxenda ampoules

metformin

Drug

biguanide antihyperglycemic

Other names: Glucophage 1000mg

Primary outcomes

  1. Body weight loss

    Time frame: 1 months

    basal body weight - body weight reached after treatment

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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