NCT01296009

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

February 15, 2011

Status Verified

November 1, 2010

Enrollment Period

6 months

First QC Date

February 14, 2011

Last Update Submit

February 14, 2011

Conditions

In Vitro Fertilization and Embryo Transfer

Keywords

embryonic implantationendometrial receptivitytraditional Chinese medicinesin vitro fertilization-embryo transferpregnant rate

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    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.

    Six months

Study Arms (1)

traditional Chinese medicine

EXPERIMENTAL

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

Drug: Traditional Chinese medicine(Zhuyun Recipe)

Interventions

Traditional Chinese medicine(Zhuyun Recipe)DRUG

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

traditional Chinese medicine

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-35 years old
  • undergo IVF/ICSI-ET treatment
  • undergo fresh/ frozen embryos transplantation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Study Officials

  • Jing Yang, Ph.D

    Renmin Hospital of Wuhan University

    STUDY CHAIR

Central Study Contacts

Nan Yu, Master's degree

CONTACT

15827012971nny86@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 15, 2011

Study Start

November 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

February 15, 2011

Record last verified: 2010-11

Locations

CN(1)