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

NCT ID: NCT04052464

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-26
• Study Completion Date: 2018-08-28

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.

Conditions

Infertility, Female; IVF

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

endometrium biopsy only

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

endometrium biopsy

Intervention Type: OTHER

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.

endometrium biopsy

Intervention Type: OTHER

All patients will have endometrium biopsy.

endometrium lavage

Intervention Type: OTHER

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.

endometrium biopsy

Intervention Type: OTHER

All patients will have endometrium biopsy.

repeated endometrium lavage

Intervention Type: OTHER

Endometrium lavage is repeated during the same cycle.

Interventions

endometrium biopsy

All patients will have endometrium biopsy.

Intervention Type: OTHER

endometrium lavage

In some selected cases biopsy is preceded by endometrium lavage.

Intervention Type: OTHER

repeated endometrium lavage

Endometrium lavage is repeated during the same cycle.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prelife Kft

INDUSTRY

Sponsor Role: lead

Responsible Party

Balint Laszlo Balint

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Balint L. Balint, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Prelife Kft

Other Identifiers

PRELIFE-V8

Identifier Type: -

Identifier Source: org_study_id