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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endometrium biopsy only | In these cases, only endometrium biopsy is investigated for the selected biomarkers gene expression profile. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endometrium biopsy | Other | All patients will have endometrium biopsy. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
The study aims to better understand the component of female infertility, therefore, is investigating only women.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Balint L. Balint, MD, PhD | Prelife Kft | Principal Investigator |
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Individual participant data will not be shared as the approval does not allow sharing of the individual participant data.
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| endometrium lavage | Other | In some selected cases biopsy is preceded by endometrium lavage. |
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| repeated endometrium lavage | Other | Endometrium lavage is repeated during the same cycle. |
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| D000091662 | Genital Diseases |
| D007246 | Infertility |