DRUG
Liraglutide and metformin
Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
Status
Recruiting
Phase
Phase 4
Enrollment
890
Locations
3
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
DRUG
Metformin 1500 mg/day until pregnancy
Timeline
First posted
Dec 19, 2024
Study start
May 22, 2025
Primary completion
May 30, 2029
Study completion
Dec 31, 2029
Results posted
Not reported
Registry updated
May 29, 2025
Outcomes
Live birth rate associated with single cycle frozen embryo transfer
Time frame · At delivery
The rate of live birth of intervention and control groups
Clinical pregnancy rate of single cycle frozen embryo transfer
Time frame · Thirty days after the embryo transplantation
Viable intrauterine pregnancy confirmed by ultrasound
Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy
Time frame · 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
Time frame · 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
Time frame · At delivery
Birth weight percentile for gestational age for neonatal sex
Apgar scores
Time frame · At delivery
Apgar scores (0\~10) of the newborns at delivery
Other perinatal outcomes
Time frame · At delivery
Rate of major birth defects, stillbirth, neonatal complications, and neonatal admission to a neonatal intensive care unit.
Accumulated live birth rate
Time frame · At delivery
Accumulated liver birth rate associated with the pregnancy achieved during the first 6 months of the study
Accumulated clinical pregnancy rate
Time frame · At month 6
Accumulated clinical pregnancy rate achieved during the first 6 months of the study
Eligibility
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 locations
China. Showing up to 24 locations stored in the fast local snapshot.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Obstetrics and Gynecology Hospital
Beijing, China
Haidian District Maternal and Child Health Care Hospital
Beijing, China
Publications
No PMID-linked publications were present in this registry snapshot.
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