The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.
Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
392
Peking University Third Hospital
Beijing, Beijing Municipality, China
Live birth rate
Time frame: 18 months
BMI change from baseline to the 3rd month in kg/m2
Time frame: 3 months
Spontaneous resumption of ovulation
Time frame: 3 months
Clinical pregnancy
Time frame: 9 months
Ongoing pregnancy
Time frame: 11 months
Pregnancy loss
Time frame: 18 months
Gestational age at delivery
Time frame: 18 months
Time to pregnancy leading to live birth
Time frame: 18 months
Hypertensive disorders of pregnancy
Time frame: 18 months
Gestational diabetes
Time frame: 18 months
Birth weight in kg
Time frame: 18 months
Neonatal mortality
Time frame: 18 months
Major congenital anomaly
Time frame: 18 months
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