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CompletedNCT02303665Updated Mar 10, 2017

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

A Phase 2 interventional study of The dual therapy and The triple therapy in Failure After Assisted Reproductive Technology, sponsored by Chengdu University of Traditional Chinese Medicine. Completed at 1 site in China. Open to female participants aged 24 Years to 43 Years. Per ClinicalTrials.gov, last updated 2017-03-10.

Sponsored by Chengdu University of Traditional Chinese Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
24 Years to 43 Years
Sex
Female
01

Study summary

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.

Read the 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

02

Conditions studied

  • Failure After Assisted Reproductive Technology

Keywords

  • TCM multi-channel therapy
  • ART failure
03

In context

Lead sponsor

Chengdu University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. People aged 20 to 45
  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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

  • Experimental
    The triple therapy group

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

    Other: The triple therapy

Interventions

  • OtherThe dual therapy

    TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy

  • OtherThe triple therapy

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

06

What researchers measure

Primary outcomes

  1. Proportion of patients with sucessful 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

07

Study locations

1 site
  • West China second University Hospital of Sichuan University
    Chendu, Sichuan 610041, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02303665
Lead sponsor
Chengdu University of Traditional Chinese Medicine
Responsible party
Huang Jinzhu (The evaluation of the curative effect onTCM joint treatment intervene in IVF-ET, Chengdu University of Traditional Chinese Medicine) — Principal investigator
First posted
Dec 1, 2014
Start date
Nov 2014
Primary completion
Dec 2015
Completion
Mar 2016
Last update
Mar 10, 2017

Study contacts

Qian Zeng
study director · Chengdu University of Traditional Chinese Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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