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

Phase 1

• Conditions: In Vitro Fertilization and Embryo Transfer
• Interventions: Drug: Traditional Chinese medicine(Zhuyun Recipe)

• Registration Number: NCT01296009
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2010-11
• Study Start: 2010-11
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Last Update Submitted: 2011-02-14
• Study First Posted: 2011-02-15
• Last Update Posted: 2011-02-15
• Primary Completion: 2011-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
traditional Chinese medicine	Traditional Chinese medicine(Zhuyun Recipe)	The pregnancy rate in traditional Chinese medicine group is higher than the control group

Primary Outcome Measures

Name	Time	Method
pregnancy rate	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.

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China