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NCT Number: NCT03078205

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

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.

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Key information

Age range

20 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West China second University Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People aged 20 to 42
  • People with IVF - ET indications
  • 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
  • People who conform to the standard of syndrome differentiation in TCM: kidney deficiency and liver depression and blood stasis
  • People with normal basic sex hormone levels
  • People who have recognized and voluntarily signed the informed consent. NOTICE: People who conform to the above 6 items can be included.

Exclusion criteria

  • People don't meet the inclusion criteria
  • The husband with less sperm and weak sperm seriously
  • People who have drug allergy or allergic constitution
  • People with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, etc. And mentally disordered patients
  • People who are complicated by acute infectious diseases and organic diseases
  • People have confirmed diagnosis malformed reproductive organs, reproductive system inflammation and tumors upon examination
  • People suffer from hereditary disease which is not suitable for fertility regulated in "maternal and infant health care law"
  • People who have the serious bad habits such as drug use
  • 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.

Treatment and study plan

The dual therapy

Other

TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy

The triple therapy

Other

TCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM

Primary outcomes

  1. Proportion of patients with successful conception

    Time frame: 10 weeks after embryo transplantation

Secondary outcomes

  1. Time to have successful conception

    Time frame: up to 26 weeks

  2. Adverse events

    Time frame: 0, 10, 26 weeks after randomization

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Registry information

Official study title

TCM Multi-channel Interventional Therapy for Assisting Reproduction

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2017
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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