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

Completed

• Conditions: Infertility, Female; IVF
• Interventions: Other: endometrium biopsy; Other: endometrium lavage; Other: repeated endometrium lavage

• Registration Number: NCT04052464
• Lead Sponsor: Prelife Kft

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.

Study Timeline

• Study Start: 2016-09-26
• Primary Completion: 2017-12-20
• Study Completion: 2018-08-28
• Status Verified: 2019-08
• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-08
• Last Update Submitted: 2019-08-08
• Study First Posted: 2019-08-09
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
endometrium lavage followed by endometrium tissue biopsy	endometrium 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.
endometrium lavage followed by endometrium tissue biopsy	endometrium lavage	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.
endometrium biopsy only	endometrium biopsy	In these cases, only endometrium biopsy is investigated for the selected biomarkers gene expression profile.
serial endometrium lavage followed by endometrium biopsy	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.
serial endometrium lavage followed by endometrium biopsy	repeated endometrium lavage	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.

Primary Outcome Measures

Name	Time	Method
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
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