Failure After Assisted Reproductive Technology Clinical Trial
Official title:
TCM Multi-channel Interventional Therapy for Assisting Reproduction
| Verified date | March 2017 |
| Source | Chengdu University of Traditional Chinese Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | March 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 24 Years to 43 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | West China second University Hospital of Sichuan University | Chendu | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| Chengdu University of Traditional Chinese Medicine |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients with sucessful conception | 10 weeks after embryo transplantation | ||
| Secondary | Time to have successful conception | up to 26 weeks | ||
| Secondary | Adverse events | 0, 10, 26 weeks after randomization |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03078205 -
Observation on the Curative Effect of Assisted Reproduction by TCM Multi-channel Interventional Therapy
|
N/A |