This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.
twice a day for 6 month
Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, China
ACTIVE_NOT_RECRUITINGGuangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong, China
ACTIVE_NOT_RECRUITINGDaqing Longnan hospital
Daqing, Heilongjiang, China
ACTIVE_NOT_RECRUITINGDaqing Oilfield General Hospital
Daqing, Heilongjiang, China
ACTIVE_NOT_RECRUITINGFirst Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGDept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine
Herbin, Heilongjiang, China
RECRUITINGMudanjiang maternal and children hospital
Mudanjiang, Heilongjiang, China
ACTIVE_NOT_RECRUITING2nd Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
ACTIVE_NOT_RECRUITINGFirst Affiliated Hospital of Hunan University of Chinese
Changsha, Hunan, China
ACTIVE_NOT_RECRUITINGSuqianMaternal and Child Health Hospital
Suqian, Jiangsu, China
ACTIVE_NOT_RECRUITING...and 8 more locations
Live birth rate
Time frame: Up to 2 years
Ovulation rate
Time frame: Up to 1 year
Miscarriage rate
Time frame: Up to 1 year
Change in hormonal profile
Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.
Time frame: Up to 1 year
Change in metabolic profile
glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.
Time frame: Up to 1 year
Change in physical measurements
weight, vital signs, and hip and waist measurements.
Time frame: Up to 1 year
Pregnancy complications
gestational diabetes, pregnancy-induced hypertension, intrauterine growth retardation, ectopic pregnancy, congenital anomaly, preeclampsia, preterm labor, HELLP syndrome, preterm premature rupture of membranes, placental abruption, placenta accreta, placenta previa, postpartum hemorrhage, and others.
Time frame: Up to 1 year
Birth defects
Time frame: Up to 1 year
Safety parameters
renal and liver function tests and complete blood count.
Time frame: Up to 1 year
Side effect profile
The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.
Time frame: Up to 1 year
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