Acupuncture and Chinese herb medicine Yangjing Zhongyu Decoction for the treatment of endometriosis-associated infertility: a multi-center, controlled and randomized clinical trial

Phase 1

Recruiting

• Conditions: endometriosis-associated infertility

• Registration Number: ITMCTR2100004830
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Women aged between 21 and 45 years with fertility intention;
2.Patients who meet the diagnostic criteria for both endometriosis and infertility;
a. Endometriosis: histopathological results: endometrial glands and stroma found in the lesion, accompanied by inflammation and fibrosis.
b. Infertility: women who fail to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse; this includes secondary infertility which is a failure to conceive after a previous pregnancy.
3.Patients who have accepted the treatment of laparoscopic conservative operation;
4.Husbands semen analysis is normal;
5.Willingness to sign the consent form.

Exclusion Criteria

1.Those who have other infertility factors (such as PCOS, tubal blockage, immune infertility, reproductive malignant tumor, reproductive organ abnormalities, and so on);
2.Those who have used other drugs that affect reproductive function or metabolism in the past 3 months;
3.Those who are not appropriate for acupuncture;
4.Those who have allergies to Chinese herbs or GnRH-a;
5.Patients with serious cardiovascular, liver, kidney, and hematopoietic system diseases;
6.Patients with infectious diseases, mental illness, and other medical histories.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCG;gestational sac;

Secondary Outcome Measures

Name	Time	Method
AMH;CA125;ALT;sex hormones;Ultrasound findings;endometriosis-specific quality of life;