Clinical trial NCT04497558: The Clinical Efficiency of Tb-ERA in Chinese RIF Patients
Official title: The Clinical Efficiency of Transcriptome-based Endometrial Receptivity Assessment (Tb-ERA) in Chinese Patients With Recurrent Implantation Failure (RIF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Receptivity
Repeated Implantation Failure
Keywords: endometrial receptivity array
Repeated implantation failure
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 months
Secondary outcomes:
measure: Endometrial implantation window evaluation results
timeFrame: 6 months
measure: Embryo implantation rate
timeFrame: 6 months
measure: Biochemical pregnancy rate
timeFrame: 6 months
measure: Early abortion rate
timeFrame: 6 months
measure: Ectopic pregnancy rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Obstetrics and Gynecology Hospital affiliated to Fudan University
name: Xiaoxi Sun
role: STUDY_CHAIR
References:
citation: Ruiz-Alonso M, Blesa D, Diaz-Gimeno P, Gomez E, Fernandez-Sanchez M, Carranza F, Carrera J, Vilella F, Pellicer A, Simon C. The endometrial receptivity array for diagnosis and personalized embryo transfer as a treatment for patients with repeated implantation failure. Fertil Steril. 2013 Sep;100(3):818-24. doi: 10.1016/j.fertnstert.2013.05.004. Epub 2013 Jun 4.
citation: Hashimoto T, Koizumi M, Doshida M, Toya M, Sagara E, Oka N, Nakajo Y, Aono N, Igarashi H, Kyono K. Efficacy of the endometrial receptivity array for repeated implantation failure in Japan: A retrospective, two-centers study. Reprod Med Biol. 2017 Jun 27;16(3):290-296. doi: 10.1002/rmb2.12041. eCollection 2017 Jul.
citation: Zhang WB, Li H, Lu X, Chen JL, Li L, Chen JC, Wu H, Sun XX. The clinical efficiency of transcriptome-based endometrial receptivity assessment (Tb-ERA) in Chinese patients with recurrent implantation failure (RIF): A study protocol for a prospective randomized controlled trial. Contemp Clin Trials Commun. 2022 May 28;28:100928. doi: 10.1016/j.conctc.2022.100928. eCollection 2022 Aug.