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

NCT ID: NCT01296009

Last Updated: 2011-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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In Vitro Fertilization and Embryo Transfer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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traditional Chinese medicine

The pregnancy rate in traditional Chinese medicine group is higher than the control group

Group Type EXPERIMENTAL

Traditional Chinese medicine(Zhuyun Recipe)

Intervention Type DRUG

The patients undergoing IVF-ET take orally traditional Chinese medicine(Zhuyun Recipe) for ten days.

Interventions

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Traditional Chinese medicine(Zhuyun Recipe)

The patients undergoing IVF-ET take orally traditional Chinese medicine(Zhuyun Recipe) for ten days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Netherlands: Ministry of Health, Welfare and Sports

OTHER_GOV

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Renmin Hospital of Wuhan University

Principal Investigators

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Jing Yang, Ph.D

Role: STUDY_CHAIR

Renmin Hospital of Wuhan University

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nan Yu, Master's degree

Role: CONTACT

15827012971

Facility Contacts

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Jing Yang, Ph.D

Role: primary

(86)-27- 88080749

Other Identifiers

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ZYF-861234

Identifier Type: -

Identifier Source: org_study_id

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