Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients

February 14, 2011 updated by: Wuhan University
To investigate the impact of traditional Chinese medicines (TCM) on embryonic implantation in the patients who have underwent in vitro fertilization and embryo transfer, the investigators compare the pregnancy rate in traditional Chinese medicine group and control group. The hypothesis is that pregnancy rate in traditional Chinese medicine group is higher than the control group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To demonstrate the impact of traditional Chinese medicine (TCM) on embryo implantation, the investigators perform a prospective randomized study on patients who have underwent in vitro fertilization and embryo transfer (IVF-ET) in the Reproductive Medical Center of the Remin Hospital Wuhan University in the next six months. These patients were randomly divided into two groups, one group was given traditional Chinese medicine, that is, ten days oral administration of Zhuyun recipe from the day after HCG injection. The second group without any treatment, and then the pregnancy rate were observed. Frozen embryo transfer for patients do the same treatment, measured indices were also the same in both groups. Our hypothesis is that Zhuyun recipe is beneficial for embryo implantation in IVF-ET patients, it can be found that pregnancy rate in traditional Chinese medicine group is higher than the control group.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nan Yu, Master's degree
  • Phone Number: 15827012971
  • Email: nny86@126.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
        • Principal Investigator:
          • Nan Yu, Master's degree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. aged 18-35 years old
  2. undergo IVF/ICSI-ET treatment
  3. undergo fresh/ frozen embryos transplantation

Exclusion Criteria:

  1. the numbers of embryos transplantation were more than one
  2. serum estradiol level > 5000 pg/ml and progesterone level > 9. 54 nmol/L on the day of HCG administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: traditional Chinese medicine
The pregnancy rate in traditional Chinese medicine group is higher than the control group
Drug: Traditional Chinese medicine(Zhuyun Recipe)
The patients undergoing IVF-ET take orally traditional Chinese medicine(Zhuyun Recipe) for ten days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: Six months
12 days after embryo transplantation, the investigators measured blood hCG level in the patients and its level > 10IU/L as a biochemical pregnancy, 4 weeks after transplantation, gestational sac and the beating heart were found as clinical pregnancy.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan University

Collaborators

Netherlands: Ministry of Health, Welfare and Sports

Investigators

  • Study Chair: Jing Yang, Ph.D, Renmin Hospital of Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2011

Last Update Submitted That Met QC Criteria

February 14, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZYF-861234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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