The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods

NCT04052464 | Completed

• 1 other identifier: PRELIFE-V8
• Study Type: observational
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to gain a better understanding of the gene expression changes in the endometrial biopsy especially whether the endometrium has reached a receptive status, i.e. the implantation window, or not.

Conditions

Infertility, Female; IVF

Keywords

gene expression; biomarkers; implantation window; embryo transfer; endometrium; biopsy; lavage; liquid biopsy

Outcome Measures

Primary Outcomes (2)

• gene expression profile

  the endometrium derived samples are measured for the mRNA level expression of a selected list of biomarkers as it follows: ABCC3, ACTB, ADAMTS2, ADAMTS8, ARG2, ASPN, B2M, BAMBI, C10orf10, C1QTNF6, C2CD4A, CCDC71L, CD55, CEBPD, CP, CRISP3, CTHRC1, CYP24A1, CSRP2, DDX52, DPP4, DUOX1, DUOXA1, EDNRB, FCER1G, G0S2, GADD45G, GNG2, GNG4, GPX3, GRAMD1C, GREM2, GZMA, HPGD, HTR2B, IGFBP1, IGFBP3, IGFBP6, IL1B, IRX3, ITGA2, ITGB6, KAL1, KCND2, KCNK3, LCP2, LEFTY2, LRP4, LTBP2, LUM, MAOA, MAP2K6, MFSD4, MMP10, MS4A7, MT1M, MUC16, NID2, NNMT, OPRK1, PAEP, PDE4B, PHLDB2, PKHD1L1, PLAT, PLD1, POLR2A, PPIA, RARRES1, RDH10, RGS1, RHOB, RHPN2, RIMKLB, SGIP1, SLAIN1, SLC15A1, SLC15A2, SLC1A1, SLC26A7, SLC5A3, SOD2, SPP1, SYT11, TBP, TCN1, TFPI2, THBS1, TIMP3, TMC5, TMED6, TNFRSF11B, TSPAN8

  measurements are performed within 3 weeks after samples are shipped to the laboratory

• endometrium phase assesment

  based on the gene expression profile endometrium samples are phase assigned based on published reference samples

  phase assignment is performed within two weeks after the measurements are performed.

Study Arms (3)

endometrium biopsy only

In these cases, only endometrium biopsy is investigated for the selected biomarkers gene expression profile.

Other: endometrium biopsy

endometrium lavage followed by endometrium tissue biopsy

In these cases before the endometrium tissue biopsy, an endometrial lavage is performed and from both samples, the selected biomarkers gene expression profile are investigated.

Other: endometrium biopsy; Other: endometrium lavage

serial endometrium lavage followed by endometrium biopsy

In these cases before the endometrium tissue biopsy, at different days endometrial lavage samples are taken. From all samples, the selected biomarkers gene expression profile are investigated.

Other: endometrium biopsy; Other: repeated endometrium lavage

Interventions

endometrium biopsy OTHER

All patients will have endometrium biopsy.

endometrium biopsy only; endometrium lavage followed by endometrium tissue biopsy; serial endometrium lavage followed by endometrium biopsy

endometrium lavage OTHER

In some selected cases biopsy is preceded by endometrium lavage.

endometrium lavage followed by endometrium tissue biopsy

repeated endometrium lavage OTHER

Endometrium lavage is repeated during the same cycle.

serial endometrium lavage followed by endometrium biopsy

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: The study aims to better understand the component of female infertility, therefore, is investigating only women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertile women participating in the diagnostic evaluation of infertility. The patients are contacted for participation in the study during the diagnostic evaluation of their infertility at specialized infertility or gynaecological clinic.

You may qualify if:

• infertile women participating in the diagnostic evaluation of infertility.

You may not qualify if:

• patients who are legally incapable or partially capable
• pregnancy should be excluded before sampling
• bleeding problems
• the active phase of severe psychiatric disorders

Sponsors & Collaborators

• Prelife Kft: lead

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Balint L. Balint, MD, PhD

  Prelife Kft

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 9, 2019
• Study Start: September 26, 2016
• Primary Completion: December 20, 2017
• Study Completion: August 28, 2018
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share