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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole combined with acupuncture and Du Meridian moxibustion group | Experimental | Letrozole combined with acupuncture and Du Meridian moxibustion was taken from 3-5 days of menstrual period (spontaneous menstruation or progesterone withdrawal bleeding). The acupuncture treatment was 3 times / week, with an interval of 2-4 days, 12 times a week, 30 minutes each time; Du Meridian moxibustion is 20 minutes each time, once a week, four times a week. The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. If not pregnant, the subjects received letrozole for up to 4 cycles to induce ovulation with acupuncture plus Du Meridian moxibustion. |
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| Letrozole group | Active Comparator | Letrozole was taken 3-5 days after menstruation (spontaneous menstruation or progesterone withdrawal bleeding). The initial dose of letrozole was 2.5mg/day for 5 consecutive days. The follow-up dose was determined according to the response of the subjects to the initial dose, with one month as a cycle. In the absence of pregnancy, subjects were treated with letrozole for up to four cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate | Ratio of the number ofdelivery of a live-born infant to the total number pregnancies of trials. | 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. | From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulation rate | Ratio of total ovulation times to the sum of the number of trials in each cycle(each cycle is 28 days). | From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days). |
| Multiple pregnancy rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| kewei Quan, attending doctor | Contact | 0086 13416820860 | 279271961@qq.com | |
| Qiuping Lin, no | Contact | 0086 15014165537 | 2758063750@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| naiping wang, Chief physician | Dongguan Hospital of Traditional Chinese Medicine | Study Director |
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The results were published within 6 months after the completion of the test.
The results were published within 6 months after the completion of the test.
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| acupuncture | Device | 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. |
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| Governor vessel moxibustion | Other | It can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation |
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The rate of multiple pregnancies to total pregnancies.
| 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. | 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 | 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. | 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. | From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days). |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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