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

Prelife Kft67 enrolled

Overview

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.

The endometrium goes through huge gene expression changes during a cycle, the cells are transformed, the mucous membrane thickens, then loosens, and finally sheds. In this process, the expression of the genes also goes through significant changes, which can be determined from a small tissue sample. Endometrium biopsy samples can be used for endometrium phasing. A question of the study is the feasibility of using for endometrium phasing beside endometrium tissue biopsy also samples generated by endometrium lavage. The advantage of this latter method is that it is minimally invasive, it does not cause haemorrhage and has minimal side effects. In some selected cases endometrial lavage will be performed on the same day with endometrial tissue sampling together with the drawing of a peripheral blood sample. A list of potential biomarkers was proposed from the meta-analysis of published gene expression datasets. From the endometrium derived samples, RNA will be isolated and gene expression biomarkers will be measured. Expression profiles will be compared to published reference samples.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Infertility, Female IVF

Interventions

endometrium biopsyOTHER

All patients will have endometrium biopsy.

endometrium lavageOTHER

In some selected cases biopsy is preceded by endometrium lavage.

repeated endometrium lavageOTHER

Endometrium lavage is repeated during the same cycle.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * infertile women participating in the diagnostic evaluation of infertility. Exclusion Criteria: * patients who are legally incapable or partially capable * pregnancy should be excluded before sampling * bleeding problems * the active phase of severe psychiatric disorders

Outcomes

Primary Outcomes

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

Time frame: 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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.