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

Prelife Kft

Status: Completed

Conditions: IVF; Infertility, Female

Treatments: Other: endometrium biopsy; Other: repeated endometrium lavage; Other: endometrium lavage

Study type: Observational

Funder types: Industry

Identifiers

NCT04052464

PRELIFE-V8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

67 participants in 3 patient groups

endometrium biopsy only

Description:

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

Treatment:

Other: endometrium biopsy

endometrium lavage followed by endometrium tissue biopsy

Description:

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.

Treatment:

Other: endometrium biopsy

Other: endometrium lavage

serial endometrium lavage followed by endometrium biopsy

Description:

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.

Treatment:

Other: repeated endometrium lavage

Other: endometrium biopsy