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

NCT03078205 | Completed DMC

• 1 other identifier: 2016SZ0037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Failure After Assisted Reproductive Technology

Keywords

TCM multi-channel therapy; ART failure

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with successful conception

  10 weeks after embryo transplantation

Secondary Outcomes (2)

• Time to have successful conception

  up to 26 weeks

• Adverse events

  0, 10, 26 weeks after randomization

Study Arms (3)

The control group

NO INTERVENTION

No Intervention

The dual therapy group

EXPERIMENTAL

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

Other: The dual therapy

The triple therapy group

EXPERIMENTAL

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

Other: The triple therapy

Interventions

The dual therapy OTHER

TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy

The dual therapy group

The triple therapy OTHER

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

The triple therapy group

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• People aged 20 to 42
• People with IVF - ET indications
• 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
• People who conform to the standard of syndrome differentiation in TCM: kidney deficiency and liver depression and blood stasis
• People with normal basic sex hormone levels
• People who have recognized and voluntarily signed the informed consent. NOTICE: People who conform to the above 6 items can be included.

You may not qualify if:

• The husband with less sperm and weak sperm seriously
• People who have drug allergy or allergic constitution
• People with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, etc. And mentally disordered patients
• People who are complicated by acute infectious diseases and organic diseases
• People have confirmed diagnosis malformed reproductive organs, reproductive system inflammation and tumors upon examination
• People suffer from hereditary disease which is not suitable for fertility regulated in "maternal and infant health care law"
• People who have the serious bad habits such as drug use
• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

West China second University Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 36267092 DERIVED

Study Officials

• Qian Zeng

  Chengdu University of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 13, 2017
• Study Start: May 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: April 1, 2018
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (1)