Observation on the Curative Effect of Assisted Reproduction by TCM Multi-channel Interventional Therapy

TCM Multi-channel Interventional Therapy for Assisting Reproduction

Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on women with ART Failure; to compare the curative effect of the dual therapy and triple therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan.

Methods: The cases with ART Failure from West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) meeting the inclusion criteria were randomly divided into three groups: the dual therapy group, the triple therapy group and the control group, compare the natural pregnancy number, the condition during the period of secondary IVF-ET and the improvement of the kidney deficiency, liver depression and blood stasis syndrome among those three groups.

Study Overview

• Status: Completed
• Conditions: Failure After Assisted Reproductive Technology
• Intervention / Treatment: Other: The dual therapy; Other: The triple therapy

Detailed Description

Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on women with ART Failure; to compare the curative effect of the dual therapy and triple therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan.

Methods: The cases with ART Failure from West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) meeting the inclusion criteria were randomly divided into three groups: the dual therapy group, the triple therapy group and the control group, compare the natural pregnancy number, the condition during the period of secondary IVF-ET and the improvement of the kidney deficiency, liver depression and blood stasis syndrome among those three groups.

The results will show the effect of TCM multi-channel interventional therapy for patients with ART failure

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chendu, Sichuan, China, 610041
      • West China Second University Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. People aged 20 to 42
2. People with IVF - ET indications
3. People from Reproductive Center of West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) with long plan for IVE - ET Failure and then accept the secondary IVF-ET
4. People who conform to the standard of syndrome differentiation in TCM: kidney deficiency and liver depression and blood stasis
5. People with normal basic sex hormone levels
6. People who have recognized and voluntarily signed the informed consent. NOTICE: People who conform to the above 6 items can be included.

Exclusion Criteria:

1. People don't meet the inclusion criteria
2. The husband with less sperm and weak sperm seriously
3. People who have drug allergy or allergic constitution
4. People with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, etc. And mentally disordered patients
5. People who are complicated by acute infectious diseases and organic diseases
6. People have confirmed diagnosis malformed reproductive organs, reproductive system inflammation and tumors upon examination
7. People suffer from hereditary disease which is not suitable for fertility regulated in "maternal and infant health care law"
8. People who have the serious bad habits such as drug use
9. People who have contacted with birth defects rays, poison, drugs to a certain number and being in effect; NOTICE: People who conform to any of the terms above 9 will be ruled out.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: The control group; No Intervention
Experimental: The dual therapy group; TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy.	Other: The dual therapy; TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy
Experimental: The triple therapy group; TCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM.	Other: The triple therapy; TCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with successful conception	10 weeks after embryo transplantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to have successful conception	up to 26 weeks
Adverse events	0, 10, 26 weeks after randomization

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Investigators: Study Director: Qian Zeng, Chengdu University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Zhou H, Zheng X, Xia W, Ma Q, Li J, Zeng Q, Huang J. The Efficacy and Safety of the Zhuyun Formula and Auricular Acupressure for the Infertile Women with Recurrent Implantation Failure: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2022 Oct 11;2022:5274638. doi: 10.1155/2022/5274638. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: TCM multi-channel therapy; ART failure
• Other Study ID Numbers: 2016SZ0037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No