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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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047212
Enrollment
Unknown
Registered
2021-06-11
Start date
2021-06-10
Completion date
Unknown
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS

Interventions

Experimental group:acupuncture

Sponsors

Dongguan Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

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

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 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 (=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 14

Design outcomes

Primary

MeasureTime frame
live birth rate;

Secondary

MeasureTime frame
Clinical pregnancy rate;Ovulation rate;

Countries

China

Contacts

Public ContactWang Naiping

Dongguan Traditional Chinese Medicine Hospital

279271961@qq.com+86 13719382194

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026