Endometrial Local Injury to Improve the Outcome of Embryo Transfer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Female Infertility Due to Nonimplantation of Ovum

Intervention / Treatment
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* Procedure: Endometrial local injury


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial local injury<br>Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy. | Procedure: Endometrial local injury<br>* 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.<br>|
| No Intervention: The blank group<br>Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | 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 | 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 | The standards is to detect fetal heart beat by ultrasound. | an expected average of 7 week after pregnancy | 
| live birth rate | The statistical ratio of live birth rate in two groups | follow-up for one year after pregnancy | 
| the rate of birth defects | calculate the rate of birth defects in two groups | follow-up for one year after pregnancy | 
| the expression changes of endometrial inflammatory factors | 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 | detection of infection by serum test | one week after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial local injury, repeated implatation failure, embyo transfer