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

NCT ID: NCT02303665

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-03-31

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.

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

Conditions

Failure After Assisted Reproductive Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The control group

No Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

The dual therapy group

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

Group Type: EXPERIMENTAL

The dual therapy

Intervention Type: OTHER

TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy

The triple therapy group

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

Group Type: EXPERIMENTAL

The triple therapy

Intervention Type: OTHER

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

Interventions

The dual therapy

TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy

Intervention Type: OTHER

The triple therapy

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

Intervention Type: OTHER

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Huang Jinzhu

The evaluation of the curative effect onTCM joint treatment intervene in IVF-ET

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qian Zeng

Role: STUDY_DIRECTOR

Chengdu University of Traditional Chinese Medicine

Locations

West China second University Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

2012SZ0086

Identifier Type: -

Identifier Source: org_study_id