Liraglutide Treatment in Obese Infertile PCOS Women

Обзор

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.

Вмешательства

• Препарат Liraglutide and metformin
  Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
• Препарат Metformin
  Metformin 1500 mg/day until pregnancy

Первичные конечные точки

• Live birth rate associated with single cycle frozen embryo transfer [Срок оценки: At delivery]

Вторичные конечные точки (8)

• Clinical pregnancy rate of single cycle frozen embryo transfer [Срок оценки: Thirty days after the embryo transplantation]
• Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy [Срок оценки: At 28 weeks of pregnancy]
• Pregnancy outcome and complications [Срок оценки: From baseline to delivery]
• Birth weight for gestational age [Срок оценки: At delivery]
• Apgar scores [Срок оценки: At delivery]
• Other perinatal outcomes [Срок оценки: At delivery]
• Accumulated live birth rate [Срок оценки: At delivery]
• Accumulated clinical pregnancy rate [Срок оценки: At month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Peking University Third Hospital — Пекин
• Beijing Obstetrics and Gynecology Hospital — Пекин
• Haidian District Maternal and Child Health Care Hospital — Пекин

Идентификаторы

NCT: NCT06742710 · LITOP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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