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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052464
• Other study ID #: PRELIFE-V8
• Status: Completed
• Start date: September 26, 2016
• Est. completion date: August 28, 2018

Study information

• Verified date: August 2019
• Source: Prelife Kft
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 28, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• IVF

Intervention

Other:
• endometrium biopsy
All patients will have endometrium biopsy.
• endometrium lavage
In some selected cases biopsy is preceded by endometrium lavage.
• repeated endometrium lavage
Endometrium lavage is repeated during the same cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prelife Kft

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.