Clinical trial NCT03078205: Observation on the Curative Effect of Assisted Reproduction by TCM Multi-channel Interventional Therapy
Official title: TCM Multi-channel Interventional Therapy for Assisting Reproduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failure After Assisted Reproductive Technology
Keywords: TCM multi-channel therapy
ART failure
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Proportion of patients with successful conception
timeFrame: 10 weeks after embryo transplantation
Secondary outcomes:
measure: Time to have successful conception
timeFrame: up to 26 weeks
measure: Adverse events
timeFrame: 0, 10, 26 weeks after randomization
Other outcomes:
Locations:
city: Chendu
country: China
facility: West China second University Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Qian Zeng
role: STUDY_DIRECTOR
References:
citation: Zhou H, Zheng X, Xia W, Ma Q, Li J, Zeng Q, Huang J. The Efficacy and Safety of the Zhuyun Formula and Auricular Acupressure for the Infertile Women with Recurrent Implantation Failure: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2022 Oct 11;2022:5274638. doi: 10.1155/2022/5274638. eCollection 2022.