Liraglutide Treatment in Obese Infertile PCOS Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liraglutide and metformin, Metformin.
- Who it may be relevant to
- Registry conditions: PCOS, Obesity, Infertility. Basic parameters: 20 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 and metformin
Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy. - Drug Metformin
Metformin 1500 mg/day until pregnancy
Primary outcome measures
- Live birth rate associated with single cycle frozen embryo transfer [Time frame: At delivery]
Secondary outcome measures (8)
- Clinical pregnancy rate of single cycle frozen embryo transfer [Time frame: Thirty days after the embryo transplantation]
- Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy [Time frame: At 28 weeks of pregnancy]
- Pregnancy outcome and complications [Time frame: From baseline to delivery]
- Birth weight for gestational age [Time frame: At delivery]
- Apgar scores [Time frame: At delivery]
- Other perinatal outcomes [Time frame: At delivery]
- Accumulated live birth rate [Time frame: At delivery]
- Accumulated clinical pregnancy rate [Time frame: At month 6]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Peking University Third Hospital — Beijing
- Beijing Obstetrics and Gynecology Hospital — Beijing
- Haidian District Maternal and Child Health Care Hospital — Beijing
Identifiers
NCT: NCT06742710 · LITOP