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

Sponsor

Prelife Kft (Industry)

Overall Status

Completed

CT.gov ID

NCT04052464

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female IVF	Other: endometrium biopsy Other: endometrium lavage Other: repeated endometrium lavage

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.

Study Design

Study Type:

Observational

Actual Enrollment :

67 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Sep 26, 2016

Actual Primary Completion Date :

Dec 20, 2017

Actual Study Completion Date :

Aug 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
endometrium biopsy only In these cases, only endometrium biopsy is investigated for the selected biomarkers gene expression profile.	Other: endometrium biopsy All patients will have 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 All patients will have endometrium biopsy. Other: endometrium lavage In some selected cases biopsy is preceded by 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 All patients will have endometrium biopsy. Other: repeated endometrium lavage Endometrium lavage is repeated during the same cycle.

Arm

Intervention/Treatment

endometrium biopsy only

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

Other: endometrium biopsy

All patients will have 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

All patients will have endometrium biopsy.

Other: endometrium lavage

In some selected cases biopsy is preceded by 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

All patients will have endometrium biopsy.

Other: repeated endometrium lavage

Endometrium lavage is repeated during the same cycle.

Outcome Measures

Primary Outcome Measures

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