Investigators expected to verify this hypothesis through this study:acupuncture and moxibustion combined with LE induced ovulation in Chinese anovulatory PCOS women has a higher rate of live birth than LE induced ovulation alone.
It is a prospective, single center, clinical, randomized, controlled study. The subjects were 90 PCOS anovulatory participants of spleen kidney yang deficiency type, aged 20-40 years, who were treated in the outpatient department of Obstetrics and Gynecology of Dongguan Hospital of traditional Chinese medicine from January 2021 to December 2022. Participants were randomly divided into two groups: Acupuncture plus Du Meridian moxibustion combined with LE ovulation induction treatment group and single Le ovulation induction control group, 45 cases in each group. The subjects in the two groups began to take letrozole or combined with acupuncture and Du Meridian moxibustion on 3-5 days of menstruation (spontaneous menstruation or progesterone withdrawal bleeding). If not pregnant, the subjects received letrozole for up to 4 cycles to induce ovulation or acupuncture plus Du Meridian moxibustion. Once pregnancy is found, acupuncture and Du Meridian moxibustion or drug treatment will stop immediately. At the end of treatment, data were collected to observe the differences of live birth rate, pregnancy rate, ovulation rate, sex hormone, steroid hormone, glucose and lipid metabolism index and safety index between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS.
Domestic and foreign studies suggest that acupuncture and electroacupuncture can improve the menstrual cycle of PCOS and reduce the level of total testosterone; Acupuncture can regulate glucose homeostasis by stimulating the autonomic nervous system of PCOS patients. Our previous studies and a large number of literatures have proved that acupuncture can improve insulin resistance in PCOS, and acupuncture can improve the pregnancy rate in PCOS.
It can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation
live birth rate
Ratio of the number ofdelivery of a live-born infant to the total number pregnancies of trials.
Time frame: Within 1 year after the end of Cycle 4 (each cycle is 28 days).
Clinical pregnancy rate
Ratio of the number of pregnancies to the total number of trials.
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Ovulation rate
Ratio of total ovulation times to the sum of the number of trials in each cycle(each cycle is 28 days).
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Multiple pregnancy rate
The rate of multiple pregnancies to total pregnancies.
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
Abortion rate
Ratio of miscarriage in the total number of pregnancies.
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).
HOMA-IR
Insulin resistance index is equal to fasting blood glucose multiplied by fasting insulin ratio 22.5. Recently, it was proposed that insulin resistance should be judged when it is greater than 2.69
Time frame: Before the trail and at the end of cycle 4.
Metabolic blood test
Number of Participants with abnormal liver function, renal function, blood lipid, blood glucose, blood pressure and other metabolic indicators.
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Time frame: Before the trail and at the end of cycle 4.
Adverse reactions
It refers to the harmful reaction that has nothing to do with the purpose of treatment in the process of using drugs to prevent, diagnose or treat diseases according to the normal usage and dosage.
Time frame: From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days).