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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Wuhan University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by:
Wuhan University
ClinicalTrials.gov Identifier:
NCT01296009
First received: February 14, 2011
Last updated: NA
Last verified: November 2010
History: No changes posted

February 14, 2011
February 14, 2011
November 2010
May 2011   (final data collection date for primary outcome measure)
pregnancy rate [ Time Frame: Six months ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
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Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients
Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
In Vitro Fertilization and Embryo Transfer
Drug: Traditional Chinese medicine(Zhuyun Recipe)
The patients undergoing IVF-ET take orally traditional Chinese medicine(Zhuyun Recipe) for ten days.
Experimental: traditional Chinese medicine
The pregnancy rate in traditional Chinese medicine group is higher than the control group
Intervention: Drug: Traditional Chinese medicine(Zhuyun Recipe)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
No
Contact: Nan Yu, Master's degree 15827012971 nny86@126.com
China
 
NCT01296009
ZYF-861234
Yes
Effect of Traditional Chinese medicine (TCM) on embryo implantation in in-vitro fertilization (IVF) patients, Renmin Hospital of Wuhan University
Wuhan University
Netherlands: Ministry of Health, Welfare and Sports
Study Chair: Jing Yang, Ph.D Renmin Hospital of Wuhan University
Wuhan University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP