NCT04052464

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 67 (actual)
• Sponsor: Prelife Kft · Industry
• Sex: Female
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	endometrium biopsy	All patients will have endometrium biopsy.
OTHER	endometrium lavage	In some selected cases biopsy is preceded by endometrium lavage.
OTHER	repeated endometrium lavage	Endometrium lavage is repeated during the same cycle.

Timeline

• Start date: 2016-09-26
• Primary completion: 2017-12-20
• Completion: 2018-08-28
• First posted: 2019-08-09
• Last updated: 2019-08-09