Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | February 14, 2011 | ||||
| Last Updated Date | February 14, 2011 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients | ||||
| Official Title ICMJE | Effect of Traditional Chinese Medicine (TCM) on Embryo Implantation in In-vitro Fertilization (IVF) Patients | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
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| Condition ICMJE | In Vitro Fertilization and Embryo Transfer | ||||
| Intervention ICMJE | Drug: Traditional Chinese medicine(Zhuyun Recipe)
The patients undergoing IVF-ET take orally traditional Chinese medicine(Zhuyun Recipe) for ten days. |
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| Study Arm (s) | 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) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | May 2011 | ||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01296009 | ||||
| Other Study ID Numbers ICMJE | ZYF-861234 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Effect of Traditional Chinese medicine (TCM) on embryo implantation in in-vitro fertilization (IVF) patients, Renmin Hospital of Wuhan University | ||||
| Study Sponsor ICMJE | Wuhan University | ||||
| Collaborators ICMJE | Netherlands: Ministry of Health, Welfare and Sports | ||||
| Investigators ICMJE |
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| Information Provided By | Wuhan University | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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