The Clinical Efficiency of Tb-ERA in Chinese RIF Patients

NCT04497558 | Completed DMC

• 1 other identifier: JIAI 2020-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Receptivity; Repeated Implantation Failure

Keywords

endometrial receptivity array; Repeated implantation failure

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Clinical pregnancy rate in patients

  6 months

Secondary Outcomes (5)

• Endometrial implantation window evaluation results

  6 months

• Embryo implantation rate

  6 months

• Biochemical pregnancy rate

  6 months

• Early abortion rate

  6 months

• Ectopic pregnancy rate

  6 months

Study Arms (2)

ERA group

EXPERIMENTAL

In the experimental group, those patients undergo endometrial receptivity array. According to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out.

Diagnostic Test: Endometrium biopsy

Control group

NO INTERVENTION

In the control group, those patients do not receive any treatment before next cycle of transfer. In the control group, no intervention will be performed.

Interventions

Endometrium biopsy DIAGNOSTIC_TEST

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.

ERA group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• People with unexplained repeated implantation failure (3 or more times of transplantation, at least 4 or more high-quality embryos failed to conceive).
• Age: 20-40 years old.
• BMI: 19 - 24.
• The thickness of endometrium is more than or equal to 7 mm.

You may not qualify if:

• Known causes of embryo implantation failure, such as infection, reproductive tract malformation, uterine cavity factors, immune factors, hydrosalpinx, etc.
• 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.
• People with genetic history.
• Those who have done abortion and the histogenetic analysis are positive.

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (3)

• 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.

  PMID: 23756099 BACKGROUND

• 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.

  PMID: 29259480 BACKGROUND

• 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.

  PMID: 35669489 DERIVED

Study Officials

• Xiaoxi Sun

  Obstetrics and Gynecology Hospital affiliated to Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 4, 2020
• Study Start: November 20, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)