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

Chengdu University of Traditional Chinese Medicine

Status and phase: Completed; Phase 2

Conditions: Failure After Assisted Reproductive Technology

Treatments: Other: The dual therapy; Other: The triple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02303665

2012SZ0086

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: Female

Ages: 24 to 43 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

The control group

No Intervention group

Description:

No Intervention

The dual therapy group

Experimental group

Description:

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

Treatment:

Other: The dual therapy

The triple therapy group

Experimental group

Description:

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

Treatment:

Other: The triple therapy