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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
890
Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
Metformin 1500 mg/day until pregnancy
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Obstetrics and Gynecology Hospital
Beijing, China
NOT_YET_RECRUITINGHaidian District Maternal and Child Health Care Hospital
Beijing, China
NOT_YET_RECRUITINGLive birth rate associated with single cycle frozen embryo transfer
The rate of live birth of intervention and control groups
Time frame: At delivery
Clinical pregnancy rate of single cycle frozen embryo transfer
Viable intrauterine pregnancy confirmed by ultrasound
Time frame: Thirty days after the embryo transplantation
Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy
Newly diagnosed diabetes or gestational diabetes at 28 weeks of pregnancy confirmed by 75 g oral glucose tolerance test。
Time frame: At 28 weeks of pregnancy
Pregnancy outcome and complications
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).
Time frame: From baseline to delivery
Birth weight for gestational age
Birth weight percentile for gestational age for neonatal sex
Time frame: At delivery
Apgar scores
Apgar scores (0\~10) of the newborns at delivery
Time frame: At delivery
Other perinatal outcomes
Rate of major birth defects, stillbirth, neonatal complications, and neonatal admission to a neonatal intensive care unit.
Time frame: At delivery
Accumulated live birth rate
Accumulated liver birth rate associated with the pregnancy achieved during the first 6 months of the study
Time frame: At delivery
Accumulated clinical pregnancy rate
Accumulated clinical pregnancy rate achieved during the first 6 months of the study
Time frame: At month 6
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