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

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ClinicalTrials.gov Identifier: NCT01296009
Recruitment Status : Unknown
Verified November 2010 by Wuhan University.
Recruitment status was:  Recruiting
First Posted : February 15, 2011
Last Update Posted : February 15, 2011
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by:
Wuhan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
In Vitro Fertilization and Embryo Transfer Drug: Traditional Chinese medicine(Zhuyun Recipe) Phase 1

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients
Study Start Date : November 2010
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2011

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296009


Contacts
Contact: Nan Yu, Master's degree 15827012971 nny86@126.com

Locations
China, Hubei
Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430060
Contact: Jing Yang, Ph.D    (86)-27- 88080749    DrYangQing@hotmail.com   
Principal Investigator: Nan Yu, Master's degree         
Sponsors and Collaborators
Wuhan University
Netherlands: Ministry of Health, Welfare and Sports
Investigators
Study Chair: Jing Yang, Ph.D Renmin Hospital of Wuhan University

Responsible Party: Effect of Traditional Chinese medicine (TCM) on embryo implantation in in-vitro fertilization (IVF) patients, Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier: NCT01296009     History of Changes
Other Study ID Numbers: ZYF-861234
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: November 2010

Keywords provided by Wuhan University:
embryonic implantation
endometrial receptivity
traditional Chinese medicines
in vitro fertilization-embryo transfer
pregnant rate