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Spots Global Cancer Trial Database for A Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth in Women With PCOS

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Trial Identification

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

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

Study ID: NCT03625531

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

The first affiliated hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Contact Details

Name: Hongxia HX Ma, Dorctor

Affiliation: The First Affiliated Hospital of Guangzhou Medical University

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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