Endometrial Local Injury to Improve the Outcome of Embryo Transfer

Not Applicable

• Conditions: Female Infertility Due to Nonimplantation of Ovum
• Interventions: Procedure: Endometrial local injury

• Registration Number: NCT02306395
• Lead Sponsor: Navy General Hospital, Beijing

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-11-22
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endometrial local injury	Endometrial local injury	Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy.

Primary Outcome Measures

Name	Time	Method
implantation rate	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.

Secondary Outcome Measures

Name	Time	Method
live birth rate	follow-up for one year after pregnancy	The statistical ratio of live birth rate in two groups
clinical pregnancy rate	an expected average of 7 week after pregnancy	The standards is to detect fetal heart beat by ultrasound.
the change of three-dimensional ultrasound of uterine cavity before and after intervention	in implantation window period(12-14 days)	including endometrial thickness, echo, blood flow and uterine cavity volume, uterine vascularization index, flow index.
infection rate	one week after intervention	detection of infection by serum test
the rate of birth defects	follow-up for one year after pregnancy	calculate the rate of birth defects in two groups
the expression changes of endometrial inflammatory factors	endometrial sampling after local injury ,in the first 3-5 days after menstrual period	Detection of inflammatory factors, such as LIF,MIP-1.; ---------------------------

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Navy General Hospital.; 🇨🇳 Beijing, Beijing, China