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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female IVF Infertility Urogenital Diseases

Age range

25 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endometrium biopsy

Other

All patients will have endometrium biopsy.

endometrium lavage

Other

In some selected cases biopsy is preceded by endometrium lavage.

repeated endometrium lavage

Other

Endometrium lavage is repeated during the same cycle.

Primary outcomes

gene expression profile

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Prelife Kft

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: Aug 9, 2019
Registry last updated: Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed