Liraglutide Treatment in Obese Infertile PCOS Women

Phase 4

Not yet recruiting

• Conditions: PCOS; Obesity; Infertility
• Interventions: Drug: Liraglutide and metformin; Drug: Metformin

• Registration Number: NCT06742710
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Liraglutide, a hypoglycemic drug, can reduce weight and improve insulin resistance while stabilizing blood glucose metabolism without increasing the risk of hypoglycemia, and has been approved by the State Food and Drug Administration of China and the US Food and Drug Administration for the treatment of obesity. Polycystic ovary syndrome (PCOS) is the main cause of female anovulatory infertility, and it is also a high-risk group of obesity. Previous studies have suggested that liraglutide improves glucose metabolism, body weight, and inflammation levels in obese women with PCOS, and improves sex hormone profiles and menstrual cycles, possibly contributing to increased fertility.

Therefore, this project intends to test the following hypothesis through a large sample randomized controlled trial in obese and infertile PCOS women who are assisted by in vitro fertilization-frozen embryo transfer (IVF-FET), using liraglutide before transplantation to reduce weight can improve the live birth rate of assisted reproduction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-04
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-19
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Study Start: 2025-02-10
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 890

Inclusion Criteria

• Women with polycystic ovary syndrome (PCOS) who meet the Rotterdam diagnostic criteria.
• Aged 20-40 years;
• 25 kg/m2 ≤ BMI ≤ 35 kg/m2;
• Have not used any anti-diabetes or weight-loss medications (metformin excluded) within the past 3 months;
• Have at least 1 transplantable frozen embryo available at the research center;
• Able to follow the study's contraceptive requirements.

Exclusion Criteria

• Diabetic ketoacidosis or other acute complications of diabetes;
• HbA1c ≥ 9.0% before enrollment;
• Using drugs that affect appetite or nutrient absorption within the past 2 months (metformin excluded);
• Uncontrolled hyperthyroidism or hypothyroidism, hypertension, systemic autoimmune diseases, etc. that may affect pregnancy and fetal development;
• 17 hydroxyprogesterone in follicualr phase > 2.0 ng/ml;
• Serious cardiovascular, digestive, liver, or kidney diseases, HBsAg-positive chronic hepatitis B, active pulmonary tuberculosis, or AIDS, etc. that are infectious or hereditary diseases;
• Any psychiatric or psychological disorders requiring drug treatment;
• Poor pregnancy and delivery history: recurrent failed implantations ≥3 times, spontaneous abortions ≥2 times; history of stillbirth, dystocia, or birth defects; previous pregnancies with preeclampsia, eclampsia, or HELLP syndrome;
• Uncontrolled metabolic, autoimmune, or hereditary disease in the husband;
• A contraindication or relative contraindication to using GLP-1 receptor agonists (history of medullary thyroid carcinoma or family history of medullary thyroid carcinoma, acute cholecystitis or pancreatitis in the acute phase or history of previous attacks, GLP-1 receptor agonist allergy, etc.);
• Failure to comply with the contraceptive requirements of the study design;
• Failure to take medication regularly and follow up;
• Current smokers, drug addicts, alcoholics, or individuals with substance abuse;
• Participants who have participated in any clinical trial within the past 3 months prior to screening;
• Individuals with other conditions deemed unsuitable for participation in this clinical trial by the investigator;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Liraglutide and metformin	Liraglutide 3.0 mg or maximum tolerable dose/day and metformin 1500 mg/day
Control Group	Metformin	Metformin 1500 mg/day

Primary Outcome Measures

Name	Time	Method
Live birth rate associated with single cycle frozen embryo transfer	At delivery	The rate of live birth of intervention and control groups

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate of single cycle frozen embryo transfer	Thirty days after the embryo transplantation	Viable intrauterine pregnancy confirmed by ultrasound
Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy	At 28 weeks of pregnancy	Newly diagnosed diabetes or gestational diabetes at 28 weeks of pregnancy confirmed by 75 g oral glucose tolerance test。
Pregnancy outcome and complications	From baseline to delivery	Rate of miscarriage, multiple pregnancies, pregnancy induced hypertension, preeclampsia, HELLP syndrome, prematurity (\< 37 weeks), macrosomia (birth weight \> 4 kg), induction of labour, prolonged duration of labour, caesarean section, assisted delivery, peripartum increased blood loss (≥ 800 ml).
Birth weight for gestational age	At delivery	Birth weight percentile for gestational age for neonatal sex
Apgar scores	At delivery	Apgar scores (0\~10) of the newborns at delivery
Other perinatal outcomes	At delivery	Rate of major birth defects, stillbirth, neonatal complications, and neonatal admission to a neonatal intensive care unit.
Accumulated live birth rate	At delivery	Accumulated liver birth rate associated with the pregnancy achieved during the first 6 months of the study
Accumulated clinical pregnancy rate	At month 6	Accumulated clinical pregnancy rate achieved during the first 6 months of the study