Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Letrozole

Liver Extracts

Progestins

Lactitol

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Two sets of acupoints will be selected for the two types. The basic acupoint-prescription includes CV 4, CV 6, CV 12 and SP 6 bilaterally, ST 25 bilaterally, EX-CA 1 bilaterally, ST 40 bilaterally and SP 9 bilaterally. Additional point ST 36 bilaterally and moxibustion as adjuvant therapy will be added for the type of yang deficiency of spleen and kidney, while additional points K 13, LR 3 for the type of yin deficiency of liver and kidney. Besides, flexible modifications of 2-3 acupoints will be performed according to patients special symptoms.

Two sets of acupuncture points will be alternated every second treatment. The first set consists of CV 3, CV 6, ST 29 bilaterally, SP 6 bilaterally, SP 9 bilaterally, GV 20 and LI 4 bilaterally. The second set consists of 13 needles: ST 25 bilaterally, ST 29 bilaterally, CV 3, CV 6, SP 6 bilaterally, LR 3 bilaterally, PC 6 bilaterally and GV 20. The following points will be connected to an electrical stimulator: ST 25 bilaterally, ST 29 bilaterally, SP 6 bilaterally, LR 3 bilaterally.

Women in the letrozole group will be given letrozole (Femara, Novartis Pharmaceuticals, Basel, Switzerland) from day 3 to day 7 of the spontaneous menstrual cycle or after a withdrawal bleeding following progestin. The maximum daily dose of letrozole will be 7.5 mg (3 pills) daily for five days.

Women will receive placebo letrozole with no acupuncture from day 3 to day 7 of the spontaneous menstrual cycle or after a withdrawal bleeding following progestin. Placebo letrozole will be given in the same way as letrozole.

Women in both personalized and fixed acupuncture groups will receive acupuncture treatment three times a week. Acupuncture treatment will start on day 3 after a spontaneous period or after a withdrawal bleeding following progestin. Each treatment session will last for 30-60 minutes, with a maximum of 48 treatment sessions over 16 weeks. If they become pregnant, the acupuncture treatment will be stopped. For personalized and fixed acupuncture group, credibility and expectancy questionnaires will be completed on the third acupuncture treatment and the last acupuncture treatment.

Acupuncture

Letrozole will be started on day 3 to day 7 of the spontaneous period or a withdrawal bleeding following progestin. If there is response with ovulation, this dose will be maintained. In those with no ovulatory response, letrozole tablets of the next ovulation cycle will be take on the day 28 of the menstrual cycle and the letrozole dose will be increased to 5 mg (2 pills) a day for 5 days. If there is still no response, the dose will be increased to 7.5 mg per day for 5 days in the next cycle. The maximum daily dose of letrozole will be 7.5 mg (3 pills) daily for five days.

Placebo letrozole will be given in the same way as letrozole. Women will receive 1 tablet a day of placebo letrozole from the day 3 to day 7 of the menstrual cycle and placebo letrozole dose will be increased 2 tablets a day in the next cycle if there is no response. The maximum daily dose of placebo letrozole will be 3 tablets daily for five days.

Placebo letrozole

Hongxia Ma, Dorctor

Hongxia HX Ma, Dorctor

Yanhua YH Zheng, Master

This study is a randomized assessor-blind controlled trial. A total of 1,100 women with PCOS will be recruited from 28 hospitals and randomly allocated into four groups: personalized acupuncture, fixed acupuncture, letrozole or placebo letrozole. Patients will receive treatment for 16 weeks and the primary outcome is live birth.

Traditional Chinese Medicine (TCM) usually involves syndrome and disease differentiation, and for acupuncture selection of appropriate points and skillful needling techniques. Many clinical trials on acupuncture used fixed acupuncture protocols without accounting for individual differences. We here design a multicenter randomized controlled trial to evaluate whether personalized or fixed acupuncture increases the likelihood of live births for infertility in women with polycystic ovary syndrome (PCOS) compared with letrozole or placebo letrozole. We hypothesis that letrozole is more effective than personalized acupuncture and that personalized acupuncture is more effective than standardized acupuncture, which is more effective than placebo letrozole.

PCOS is a complex reproductive-metabolic disorder, affects 5-10% of reproductive age women and is the most common cause of anovulatory infertility.

A Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth in Women With PCOS

A Multicenter Randomized Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth for Infertility in Women With Polycystic Ovary Syndrome

Live birth rate defined as a delivery after ≥20 weeks gestation.

Ovulation defined as a serum progesterone level \>3 ng/mL on day 21 or day 28 of the cycle.

Conception defined as positive serum hCG.

Pregnancy loss defined as pregnancy loss occurring from conception to 27 completed weeks of gestational age.

SF-36 is one of questionnaires for assessments of health-related quality of life. It includes 36 items, the scores for each domain range from 0 to 100, with high scores indicating a better status.

PCOSQ is one of questionnaires for assessments of health-related quality of life. It concludes 26 items. Each question is associated with a 7-point scale in which 7 represents optimal function and 1 represents the poorest function.

ChQOL is one of questionnaires for assessments of health-related quality of life. The ChQOL is unique in that it is a health-related quality of life （HRQOL） measure specific to Traditional Chinese Medicine (TCM). ChQOL consists of 50 items ,each item is rated on a five-point Likert scale with higher scores indicating better HRQOL.

Zung SAS is one of questionnaires for symptoms of anxiety and depression. For the SAS, index score of 50 is a cut-off point for clinically significant anxiety, with higher score suggesting more serious depression.

Zung SDS is one of questionnaires for symptoms of anxiety and depression. Index scores of 25 to 49 indicate nil depression, 50-59 indicate mild to moderate depression, 60-69 indicate moderate to severe depression, and scores over 70 indicate severe depression.

Adverse events will be categorized and percentage of patients experiencing. adverse events and serious adverse events during the treatment period will be documented.

Spots Global Cancer Trial Database for placebo letrozole