The Embryo-endometrium Multifaceted Interface: Endometrial Cavity Molecular Microbiobial and Transcriptomic Signatures in Predictinf Pregnancy Outcome in Infertile Patients Undergoing Assisted Reproduction Technology Procedures

San Donato Group (GSD)

Status: Active, not recruiting

Conditions: Infertility (IVF Patients)

Study type: Observational

Funder types: Other

Identifiers

NCT07085585

RF-2019-12369460 (Other Grant/Funding Number)

Details and patient eligibility

About

In reproductive medicine, a fundamental challenge is to evaluate the endometrial health status during the embryo implantation window as a limiting step in predicting the success of treatments of assisted reproduction technology (ART). Some highthroughput tools, recently developed by private genomics companies, are available in the market even if they have not been independently validated and have different limitations. We propose a prospective cohort study with the aim of validating the reliability and increasing efficacy of these tools. Endometrial fluid samples will be collected non-invasively from women undergoing ART cycles and isolated genetic materials will be subjected to 16S rRNA gene sequencing for microbiota profiling and to RNAseq analysis of RNA content of extracellular vesicles previously recognized as a tissue proxy in predicting endometrial receptivity. Clinical pregnancy rate/first cycle will be the target outcome used to assess the resulting predictive models. Ultrasonographic features of the endometrium will also be collected and accounted for in the predictive model.

Enrollment: 322 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

IVF Patients inclusion Criteria:

• Indication to ART
• Age 18-39 years
• First ART cycle
• Normal uterine morphology and no hydrosalpinx at ultrasound

IVF Patients exclusion Criteria:

• Poor responders according to Bologna criteria
• Indications to ART for severe male infertility

Fertile Patients inclusion Criteria:

• Subjects will be cycling women with proven fertility undergoing laparoscopy for tubal ligation
• BMI < 30
• Aged 20 to 40 years

Fertile Patients exclusion Criteria:

• Smokers
• Not taking any medication

Trial design

322 participants in 2 patient groups

fertile women

Description:

Reference group

infertile women undergoing ART cycles

Description:

Cases group