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Trial record 18 of 3024 for:    China Medicine University Hospital

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

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ClinicalTrials.gov Identifier: NCT03078205
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Huang Jinzhu, Chengdu University of Traditional Chinese Medicine

Brief 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.


Condition or disease Intervention/treatment Phase
Failure After Assisted Reproductive Technology Other: The dual therapy Other: The triple therapy Phase 2

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TCM Multi-channel Interventional Therapy for Assisting Reproduction
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : May 1, 2018

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




Primary Outcome Measures :
  1. Proportion of patients with successful conception [ Time Frame: 10 weeks after embryo transplantation ]

Secondary Outcome Measures :
  1. Time to have successful conception [ Time Frame: up to 26 weeks ]
  2. Adverse events [ Time Frame: 0, 10, 26 weeks after randomization ]


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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078205


Contacts
Contact: Jinzhu Huang, Master 86-18981885627 kjchjz@163.com

Locations
China, Sichuan
West China second University Hospital of Sichuan University Recruiting
Chendu, Sichuan, China, 610041
Contact: Jinzhu Huang, MD    028-85503960      
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
Study Director: Qian Zeng 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
ClinicalTrials.gov Identifier: NCT03078205     History of Changes
Other Study ID Numbers: 2016SZ0037
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Huang Jinzhu, Chengdu University of Traditional Chinese Medicine:
TCM multi-channel therapy
ART failure