Liraglutide and Metformin Combination on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With PCOS, Obesity and Infertility

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and one of the leading causes of infertility. PCOS and obesity affect up to 12.5% - 48.3% Asian women, increase incidence of impaired glucose tolerance, type 2 diabetes and aggravate insulin resistance, cause ovulatory dysfunction and menstrual disorders, and negatively impact outcomes of Assited Reproductive Technology (ART), with higher miscarriage rate when receiving ART. Weight loss decrease insulin resistance and hyperandrogenism, improve ovulation rate and menstrual cycle, significantly higher conception and live birth rates. Weight loss prior to IVF procedures has been associated with significantly improved pregnancy rates (PR) and live birth rates. Furthermore, a decreased number of IVF cycles required to achieve a pregnancy has also been reported after weight loss interventions. Based on the principles of fetal programming, improving a lifestyle before conception might lead to improved longterm health of the offspring. Studies on the effect of anti-obesity medication combined with lifestyle changes on body weight and composition and metabolic - endocrine parameters and pregnancy rate in obese women diagnosed with PCOS are lacking. There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mỹ Đức Hospital
• Treatments: Liraglutide; Metformin

Criteria

Inclusion Criteria:

• Female gender

• 18-65 years of age

• Diagnosis of polycystic ovary syndrome according to the revised Rotterdam criteria (2003)

• BMI ≥ 27 kg/m2

• Infertility

• Agree to participate in the study

Exclusion Criteria:

• Type 1 or type 2 diabetes.

• History of acute or chronic pancreatitis.

• Family or individual history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

• Known hypersensitivity or contraindication to the use of GLP-1 receptor agonists.

• Used of hormonal drugs, drugs causing clinically significant weight changes and drugs affecting glucose tolerance for at least 8 weeks.

• Used a anti-androgen drugs for at least 4 weeks.

• History of malignancy requiring chemotherapy.

• History of taking antidiabetic drugs other than gestational diabetes or weight-loss drugs discontinued for at least 4 weeks.

• History of gastrectomy or device-based intervention to manage obesity

• Eating disorders (anorexia or bulimia) or digestive disorders.

• Substance abuse (Tobacco or alcohol)

• History of major depression or other serious mental disorder.

• Inability or refusal to adhere treatment regimens.