Infertility (IVF Patients)
Conditions
Keywords
Extracellular Vesicles, endometrial microbiome, RNA-Seq
Brief summary
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.
Interventions
None listed
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IRCCS San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of endometrial microbiome diversity | through study completion, an average of 1 year | Evaluation of the endometrial microbiome composition and diversity using 16S rRNA sequencing to assess the functional impact of the endometrial microbial community in predicting the clinical pregnancy rate in women undergoing ART cycles. |
| Extracellular Vesicle (EV) RNA Profiles | through study completion, an average of 1 year | Quantification of extracellular vesicle (EV) RNA expression profiles from uterine fluid samples using RNA sequencing (expressed in CPM). Confirmation of the good correlation between expression of genes in tissue samples and in endometrial-derived EVs. |
| Integrated Predictive Model for Clinical Pregnancy | through study completion, an average of 1 year | Development of a multivariable predictive model combining endometrial microbiome diversity, EV RNA profiles, and ultrasound-AI analysis to predict clinical pregnancy rates in ART cycles. |
Countries
Italy
Outcome results
None listed