Female Infertility Due to Nonimplantation of Ovum
Conditions
Keywords
endometrial local injury, repeated implatation failure, embyo transfer
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.
Interventions
PROCEDUREEndometrial 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.
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| clinical pregnancy rate | an expected average of 7 week after pregnancy | The standards is to detect fetal heart beat by ultrasound. |
| 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. \--------------------------- |
| live birth rate | follow-up for one year after pregnancy | The statistical ratio of live birth rate in two groups |
Countries
China
Contacts
Primary ContactYi Li
Outcome results
None listed