The Clinical Trial of Acupuncture Pre-treatment on PCOS
Status:
Completed
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
This is a study protocol for a multicenter, randomized, and controlled trial. In this
protocol, we present a randomized controlled trial comparing acupuncture pretreatment
followed by letrozole vs letrozole alone in polycystic ovary syndrome (PCOS) women with
anovulatory infertility. The high prevalence of insulin resistance (IR) in women with PCOS
women is considered to be one of the major pathophysiological changes of PCOS, leading to
anovulatiory infertility. A study has shown that electro-acupuncture could significantly
improve insulin sensitivity. The effect of acupuncture pretreatment on anovulatory PCOS women
followed by ovulation induction has not been investigated before. A total of 384 patients
enrolled in this study will be randomized into one of two groups. The treatment group: a 16
week acupuncture pretreatment followed by 4 cycles of letrozole and the control group: 4
cycles of letrozole alone. The primary outcome is the live birth rate. We postulate that
acupuncture pretreatment followed by letrozole results in a higher live birth rate when
compared with letrozole alone.
Phase:
Phase 3
Details
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Collaborators:
Hexian Memorial Affiliated Hospital of Southern Medical University Karolinska Institutet The University of Hong Kong Xuzhou Maternity and Child Health Care Hospital