To evaluate the efficacy and safety of Dual GIP/GLP-1 receptor agonist pretreatment on reproductive outcomes in obese women before frozen embryo transfer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,510
16 weeks treatment
RenJi Hospital
Shanghai, Shanghai Municipality, China
Good birth outcome rate
good birth outcome is defined as live birth(s) at ≥37 weeks, with infant birth weight between 2500 and 4000g and without a major congenital anomaly.
Time frame: at delivery
Biochemical pregnancy rate
biochemical pregnancy is defined as serum beta-human chorionic gonadotropin (β-hCG) ≥10 mIU/ml.
Time frame: 12-17 days after frozen embryo transfer
Clinical pregnancy rate
clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac.
Time frame: 28-35 days after frozen embryo transfer
Implantation rate
implantation rate is calculated as the number of gestational sacs by a transvaginal ultrasound scan/number of embryos transferred.
Time frame: 28-35 days after frozen embryo transfer
Pregnancy loss rate
pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.
Time frame: From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months
Live birth rate
live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.
Time frame: at delivery
Gestational weight gain
maternal weight gain during pregnancy.
Time frame: at delivery
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Incidences of obstetric and neonatal complications
including gestational diabetes mellitus, pre-eclampsia, placenta previa, placental abruption, congenital anomalies, postpartum hemorrhage, preterm birth, neonatal respiratory distress syndrome, neonatal jaundice, neonatal infection, neonatal death, etc.
Time frame: From the establishment of clinically recognized pregnancy until six weeks after delivery
Incidence of composite endpoint of obesity-related pregnancy complications
composite incidences of miscarriage, gestational diabetes mellitus, hypertensive disorders of pregnancy, and preterm birth.
Time frame: From the establishment of clinically recognized pregnancy until six weeks after delivery
Birth weight
birth weight of the newborn at delivery.
Time frame: at delivery
Incidence of congenital anomalies
congenital malformations or birth defects.
Time frame: From the establishment of clinically recognized pregnancy until six weeks after delivery