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New treatment option for PCOS
Official title Liraglutide Treatment in Obese Infertile PCOS Women
ClinicalTrials.gov ID: NCT06742710
What this study is testing
What is Liraglutide and metformin?
Liraglutide and metformin is an investigational medicine, being studied as a potential treatment for pcos.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 40, women only
You may be able to join if
- 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;
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.