Traditional Chinese Medicine Sequential Treatment for Endometriosis Associated Infertility

Summary

Endometriosis is a common, chronic disease. 30% to 50% of women with endometriosis are infertile. There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis increases live birth or ongoing pregnancy rates. There was no evidence of benefit for post-surgical hormonal suppression of endometriosis compared to surgery alone for the outcomes of pregnancy rates. Past studies have confirmed that Chinese herbal medicine can inhibit post-surgical endometriosis recurrence, increase pregnancy rate.This study evaluates the efficacy and safety of Traditional Chinese Medicine Sequential Treatment of endometriosis-associated infertility. The study objective is to confirm that clinical pregnancy rate of patients with endometriosis-associated infertility post-conservative surgery accepting Chinese medicine activating blood, dredging liver and nourishing kidney sequential treatment is higher than expectant treatment.

Conditions

• Endometriosis
• Infertility

Interventions

DRUG

pre-ovulation Decoction

HuoXueXiaoYi Decoction(Bupleurum 10g, Cyperus 10g, Salvia miltiorrhiza 20g, Red peony 10g,etc)has activating blood and absorbing clots effect, can inhibit the growth of ectopic endometrium, promote follicular growth, maturity, improve ovulation and the receptivity of endometrium.

DRUG

post-ovulation Decoction

BuShenZhuYun Decoction(Bupleurum 10g,Poria 15g, Atractylodes 15g,Ligustrum 15g,etc) has dredging liver and nourishing kidney effect, can improve the function of corpus luteum. All are made into granules.

DRUG

pre-ovulation Decoction(placebo)

Composition of maltodextrin, lactose, edible pigment, taste masking agent.

DRUG

post-ovulation Decoction(placebo)

Composition of maltodextrin, lactose, edible pigment, taste masking agent.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  collaborator OTHER

• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

  collaborator OTHER

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  lead OTHER

Principal Investigators

• Ruihua Zhao, Doctor · Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2017-05-31

Completion

2017-12-31

Countries

• China

Study Locations