Infertility, Female, IVF
Conditions
Keywords
gene expression, biomarkers, implantation window, embryo transfer, endometrium, biopsy, lavage, liquid biopsy
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.
Detailed description
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.
Interventions
OTHERendometrium biopsy
All patients will have endometrium biopsy.
OTHERendometrium lavage
In some selected cases biopsy is preceded by endometrium lavage.
OTHERrepeated endometrium lavage
Endometrium lavage is repeated during the same cycle.
Sponsors
Prelife Kft
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gene expression profile | measurements are performed within 3 weeks after samples are shipped to the laboratory | 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 |
| endometrium phase assesment | phase assignment is performed within two weeks after the measurements are performed. | based on the gene expression profile endometrium samples are phase assigned based on published reference samples |
Outcome results
None listed