Endometrial Local Injury to Improve the Outcome of Embryo Transfer

January 4, 2016 updated by: Yunhai Chuai, Navy General Hospital, Beijing

Endometrial Local Injury of Frozen Cycle to Improve the Outcome of Embryo Transfer of Repeated Implantation Failure.

The purpose of this study is to determine whether edometrial local injury improves the outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of intervention,and the possible mechanism.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is important to evaluate the efficacy of endometrial local injury in assisted reproductive technology(ART),especially on the patients of recurrent implantation failure. Although most trials proved the effectiveness of the intervention of local injury, the subjects of these trials are rarely the patients of repeated implantation failure(RIF). Moreover, the mechanism of endometrial injury is not clear.Our trial may provide further basis for this purpose by comparing to the quality of endometrium in two-dimensional ultrasound.If the technique demonstrates efficacy, it would help the patients with RIF caused by poor conditions of endometrium to deal with the problem of infertility.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • Recruiting
        • Department of Obstetrics and Gynecology, Navy General Hospital.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with RIF(≥2) of embyo transfer and uneven echo of endometrium on HCG day(12-14 days)
  • Without operation history of uterine cavity in the previous three months
  • Who agree to join in the study

Exclusion Criteria:

  • Women more than 40 years or less than 20 years
  • With infectious diseases or endocrine diseases
  • Who refuse to participate in the experiment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endometrial local injury
Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy.
Procedure: Endometrial local injury
The way of intervention is to scratch the uterine cavity two cycles by a small spatula in the first 3-5 days after menstrual period.
No Intervention: The blank group
Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implantation rate
Time Frame: 3 months after intervention
When serum HCG is continuously more than 100mIU/ml and gestational sac is detected by ultrasound,it is considered as implantation.
3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of three-dimensional ultrasound of uterine cavity before and after intervention
Time Frame: in implantation window period(12-14 days)
including endometrial thickness, echo, blood flow and uterine cavity volume, uterine vascularization index, flow index.
in implantation window period(12-14 days)
clinical pregnancy rate
Time Frame: an expected average of 7 week after pregnancy
The standards is to detect fetal heart beat by ultrasound.
an expected average of 7 week after pregnancy
live birth rate
Time Frame: follow-up for one year after pregnancy
The statistical ratio of live birth rate in two groups
follow-up for one year after pregnancy
the rate of birth defects
Time Frame: follow-up for one year after pregnancy
calculate the rate of birth defects in two groups
follow-up for one year after pregnancy
the expression changes of endometrial inflammatory factors
Time Frame: endometrial sampling after local injury ,in the first 3-5 days after menstrual period

Detection of inflammatory factors, such as LIF,MIP-1.

---------------------------
endometrial sampling after local injury ,in the first 3-5 days after menstrual period
infection rate
Time Frame: one week after intervention
detection of infection by serum test
one week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

  • Principal Investigator: Aiming Wang, Dr, Navy General Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 22, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Female Infertility Due to Nonimplantation of Ovum

Clinical Trials on Endometrial local injury

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe