The Clinical Efficiency of Tb-ERA in Chinese RIF Patients

Endometrial Receptivity Clinical Trial

Official title:

The Clinical Efficiency of Transcriptome-based Endometrial Receptivity Assessment (Tb-ERA) in Chinese Patients With Recurrent Implantation Failure (RIF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497558
• Other study ID #: JIAI 2020-07
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2020
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: Wenbi Zhang
• Phone: +8602163459977
• Email: jackeyzhang0905[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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: ? 10u / L < basal follicle stimulating hormone (FSH) < 25U / L, and / or estradiol (E2) > 292.8pmol/l, and / or FSH / LH > 3; ? 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.

Related Conditions & MeSH terms

• Endometrial Receptivity
• Repeated Implantation Failure

Intervention

Diagnostic Test:
• Endometrium 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.

Locations

Country	Name	City	State
China	Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

Ruiz-Alonso M, Blesa D, Díaz-Gimeno P, Gómez E, Fernández-Sánchez M, Carranza F, Carrera J, Vilella F, Pellicer A, Simón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Clinical pregnancy rate in patients	6 months
Secondary	Endometrial implantation window evaluation results	Endometrial implantation window evaluation results in tested patients	6 months
Secondary	Embryo implantation rate	Embryo implantation rate in patients	6 months
Secondary	Biochemical pregnancy rate	Biochemical pregnancy rate in patients	6 months
Secondary	Early abortion rate	Early abortion rate in patients	6 months
Secondary	Ectopic pregnancy rate	Ectopic pregnancy rate in patients	6 months