Endometrial Receptivity, Repeated Implantation Failure
Conditions
Keywords
endometrial receptivity array, Repeated implantation failure
Brief summary
In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.
Detailed description
In the field of assisted reproduction techonology, there are still 10% of patients with repeated implantation failure. In order to further explore the clinical utility of endometrial receptivity array in patients with repeated implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed. Statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (endometrial implantation window evaluation results, embryo implantation rate, biochemical pregnancy rate, early abortion rate, ectopic pregnancy rate) are done. Through the comparative analysis of clinical outcomes to verify the clinical efficacy of endometrial receptivity analysis in patients with repeated implant failure, this method will provide a new treatment for repeated implant failure population.
Interventions
DIAGNOSTIC_TESTEndometrium biopsy
In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed.
Sponsors
ShangHai Ji Ai Genetics & IVF Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. People with unexplained repeated implantation failure (3 or more times of transplantation, at least 4 or more high-quality embryos failed to conceive). 2. Age: 20-40 years old. 3. BMI: 19 - 24. 4. The thickness of endometrium is more than or equal to 7 mm.
Exclusion criteria
1. Known causes of embryo implantation failure, such as infection, reproductive tract malformation, uterine cavity factors, immune factors, hydrosalpinx, etc. 2. Decreased ovarian function (meet the following at least two criteria: ① 10u / L \< basal follicle stimulating hormone (FSH) \< 25U / L, and / or estradiol (E2) \> 292.8pmol/l, and / or FSH / LH \> 3; ② the number of antral follicles \< 5-7 on the second to third day of menstruation; and (or) antimullerian hormone (AMH) \< 0.5-1.1ng/ml. 3. People with genetic history. 4. Those who have done abortion and the histogenetic analysis are positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 6 months | Clinical pregnancy rate in patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial implantation window evaluation results | 6 months | Endometrial implantation window evaluation results in tested patients |
| Embryo implantation rate | 6 months | Embryo implantation rate in patients |
| Biochemical pregnancy rate | 6 months | Biochemical pregnancy rate in patients |
| Early abortion rate | 6 months | Early abortion rate in patients |
| Ectopic pregnancy rate | 6 months | Ectopic pregnancy rate in patients |
Countries
China
Outcome results
None listed