The Clinical Trial of Acupuncture Pre-treatment on PCOS

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

OTHER

Pre-treatment acupuncture

Acupuncture treatment will start on day 3-5 after a spontaneous period or after a withdrawal bleeding following progestin. They will receive acupuncture treatment three times a week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 16 weeks.

DRUG

Letrozole

Starting from 2.5mg daily from day 3-5 for 5 days after a spontaneous period or after a withdrawal bleeding following progestin, one time per day.Participants are treated for up to 4 cycles.

Sponsors & Collaborators

• The University of Hong Kong

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Xuzhou Maternity and Child Health Care Hospital

  collaborator OTHER

• Hexian Memorial Affiliated Hospital of Southern Medical University

  collaborator UNKNOWN

• The First Affiliated Hospital of Guangzhou Medical University

  lead OTHER

Principal Investigators

• Hongxia Ma, PhD · The First Affiliated Hospital of Guangzhou Medical University

• Juan Li, PhD · The First Affiliated Hospital of Guangzhou Medical University

• Elisabet Stener-Victorin, PhD · Karolinska Institutet

• Ernest HY NG, PhD · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2019-10-31

Completion

2019-10-31

Countries

• China

Study Locations