Infertility, Female, PCOS
Conditions
Keywords
PCOS, acupuncture, Governor vessel moxibustion, spleen-kidney Yang deficiency, letrozole
Brief summary
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.
Detailed description
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.
Interventions
DRUGLetrozole
Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS.
DEVICEacupuncture
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.
OTHERGovernor vessel moxibustion
It can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation
Sponsors
Qiu-ping Lin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women between the ages of 20 and 40. * It meets the diagnostic criteria of spleen-kidney Yang deficiency type PCOS. * According to World Health Organization standards (2010), the husband's semen analysis meets ① or ②.①Sperm density ≥15×10\^6/ml, and motile sperm (forward and non-forward) ≥40% (A + B + C ≥40%)).② Total motile sperm number ≥9 million.That is, the percentage of semen volume × semen density × motility sperm ≥9×10\^6. * Tubal patency tests, including hysterosalpingography and diagnostic laparoscopy, which show that at least one fallopian tube is open.(If there is no history of pelvic operation or abortion, patency test results are effective within 3 years;If there is a history of fertility within 5 years and there is no pelvic operation, the tubal patency test is not required). * Agree to discontinue the use of other therapies during the study. 6) Participate in the study voluntarily and sign the informed consent.
Exclusion criteria
* Eliminate other endocrine disorders: ① Patients with hyperprolactinemia (defined as two prolactin levels greater than or equal to 25ng/ml or determined by local standard values at least one week apart).The goal of excluding patients with hyperprolactinemia was to reduce variability among PCOS patients.These patients may be treated with alternative therapies (e.g., dopamine agonists).Those who had received treatment within the past year or were receiving treatment with normal test values could be enrolled. ② Menopausal FSH level (\> 15 mIU/mL).Normal levels in the past year are eligible for inclusion. ③ Patients with uncorrected thyroid disease (defined as TSH \< 0.2 mIU/mL or \>5.5 mIU/mL).In the past year, normal levels can be included in the group. ④ Patients with poorly controlled type I or II diabetes (defined as a bb0 7.0% glycosylated hemoglobin level) or patients receiving antidiabetic drugs such as insulin, thiazole-lowering drugs, acarbose, or sulfonylureas may obfuscate the effects of the study drugs;Patients who were being treated with metformin in order to be diagnosed with type I or II diabetes or PCOS also need to be excluded. ⑤ Suspected patients with Cushing syndrome. * In the last 2 months, use of hormones or other drugs, including TCM prescriptions and Chinese patent medicines, may affect the results. * Pregnancy history within the last 6 weeks. * A history of miscarriage or birth in the last 6 weeks. * A history of breastfeeding in the last 6 months. * Do not agree to sign the informed consent for this study. * PCOS women who do not belong to the syndrome of spleen-kidney Yang deficiency. * Special
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| live birth rate | Within 1 year after the end of Cycle 4 (each cycle is 28 days). | Ratio of the number ofdelivery of a live-born infant to the total number pregnancies of trials. |
| Clinical pregnancy rate | From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days). | Ratio of the number of pregnancies to the total number of trials. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abortion rate | From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days). | Ratio of miscarriage in the total number of pregnancies. |
| HOMA-IR | Before the trail and at the end of cycle 4. | 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 |
| Ovulation rate | From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days). | Ratio of total ovulation times to the sum of the number of trials in each cycle(each cycle is 28 days). |
| Adverse reactions | From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days). | 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. |
| Metabolic blood test | Before the trail and at the end of cycle 4. | Number of Participants with abnormal liver function, renal function, blood lipid, blood glucose, blood pressure and other metabolic indicators. |
| Multiple pregnancy rate | From the beginning to 14 days after the end of cycle 4 (each cycle is 28 days). | The rate of multiple pregnancies to total pregnancies. |
Contacts
Primary Contactkewei Quan, attending doctor
Backup ContactQiuping Lin, no
Outcome results
None listed