Liraglutide Treatment in Obese Infertile PCOS Women

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called liraglutide on women who are obese and have polycystic ovary syndrome (PCOS), a condition that can affect fertility. The researchers want to find out if taking liraglutide before undergoing a specific fertility treatment known as in vitro fertilization (IVF) can help improve the chances of having a baby. Liraglutide is already approved for helping with weight loss and managing blood sugar levels, and past studies suggest it might also help with symptoms related to PCOS, such as hormone imbalances and irregular menstrual cycles.

To join the study, participants need to be women aged 20 to 40 who have been diagnosed with PCOS and have a body mass index (BMI) between 25 and 35. They should also have at least one frozen embryo available for the IVF procedure and not have used certain medications recently. During the trial, participants will take liraglutide and be monitored closely. It's important to know that this trial is not yet recruiting participants, and there are specific health conditions that may prevent someone from participating, such as certain diabetes-related issues, serious diseases, or a history of complications in previous pregnancies.

Gender

FEMALE

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;