Effect of acupuncture plus Governor vessel moxibustion combined with letrozole on live birth in anovulatory infertile women with spleen-kidney Yang deficiency polycystic ovary syndrome: a randomised controlled trial

Phase 1

Recruiting

• Conditions: PCOS

• Registration Number: ITMCTR2100004939
• Lead Sponsor: Dongguan Traditional Chinese Medicine Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Women aged 20 to 40 years;
2. It meets the diagnostic criteria of spleen-kidney Yang deficiency type PCOS;
3. According to World Health Organization standards (2010), the husband's semen analysis meets (1) or (2):
(1) Sperm density >= 15x10^6/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 x semen density x motility sperm >= 9x10^6;
4. 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);
5. Agree to discontinue the use of other therapies during the study;
6. Participate in the study voluntarily and sign the informed consent.

Exclusion Criteria

1. 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;
2. In the last 2 months, use of hormones or other drugs, including TCM prescriptions and Chinese patent medicines, may affect the results;
3. Pregnancy history within the last 6 weeks;
4. A history of miscarriage or birth in the last 6 weeks;
5. A history of breastfeeding in the last 6 months;
6. Special exclusion criteria:
(1) Patients with adrenal or ovarian tumors suspected of producing androgens;
(2) Both the husband and wife have had sterilization operations (vasectomy, tubal ligation) before, and the ligation has been loosened.Previous surgery may have influenced the results of the study.Patients with both husband and wife having undergone sterilization and PCOS at the same time are rare, and the inclusion of these patients should be excluded, otherwise the progress of this study will be affected;
(3) Patients who have had bariatric surgery recently (<12 months) and who are in a period of dramatic weight loss or who have had bariatric surgery to prohibit pregnancy;
(4) Untreated hypertensive patients with poor blood pressure control were defined as >=60min between two blood pressure measurements, >=160 mm Hg systolic or >=100 mm Hg diastolic;
(5) Patients with known congenital adrenocortical hyperplasia;
(6) Oral contraceptives, progesterone or hormone implants (including subcutaneous implants).A 2-month clearance period is required before screening of patients who have received these drugs.Storage of contraceptive forms or implants, especially if the implants have not been removed, may require longer removal time.Oral contraceptives take about a month to clear the drug;
(7) Patients with liver disease with AST or ALT >2 times normal value or total bilirubin >2.5 mg/dL.Patients with nephropathy with BUN > 30 mg/dL or serum creatinine > 1.4 mg/dL;
(8) Patients with significant anemia (hemoglobin < 10 g/dL);
(9) Patients with a history of deep vein thrombosis, pulmonary embolism, or cerebrovascular disease;
(10) Patients with heart disease that may worsen after pregnancy;
(11) Patients with a suspected history of cervical, endometrial or breast cancer.Women 21 years of age and older should have normal results from a Pap smear or TCT test;
(12) Patients with a current history of alcoholism.Binge drinking was defined as > 14

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
live birth rate;

Secondary Outcome Measures

Name	Time	Method
Ovulation rate;Clinical pregnancy rate;