Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
In Vitro Fertilization and Embryo Transfer |
Drug: Traditional Chinese medicine(Zhuyun Recipe) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients |
- 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.
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- aged 18-35 years old
- undergo IVF/ICSI-ET treatment
- undergo fresh/ frozen embryos transplantation
Exclusion Criteria:
- the numbers of embryos transplantation were more than one
- serum estradiol level > 5000 pg/ml and progesterone level > 9. 54 nmol/L on the day of HCG administration
Contacts and Locations| Contact: Nan Yu, Master's degree | 15827012971 | nny86@126.com |
| 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 | |
| Study Chair: | Jing Yang, Ph.D | Renmin Hospital of Wuhan University |
More Information
No publications provided
| 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 |
| Study First Received: | February 14, 2011 |
| Last Updated: | February 14, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Wuhan University:
|
embryonic implantation endometrial receptivity traditional Chinese medicines in vitro fertilization-embryo transfer pregnant rate |
ClinicalTrials.gov processed this record on May 21, 2013