Research of Predictive Factors of in Vitro Fertilization (IVF) Outcome AI-IVF Study (AI-IVF)

Research of Predictive Factors of in Vitro Fertilization (IVF) Outcome in Women Affected by Autoimmune Disorders: from Biological Markers to Artificial Intelligence

Infertility is the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected intercourse, while subfertility means a delay in achieving pregnancy. Several factors can contribute to these conditions, such as autoimmune diseases like systemic thyroid and celiac diseases, rheumatoid arthritis, systemic lupus erythematosus, and endometriosis. Some of them may overlap, sharing a common immunological milieu.

In this scenario, medically ART can help women carry on pregnancies if they are in stable disease remission and receive adequate treatment. However, the number of oocytes that can be ovulated under stimulation is highly variable, so the outcome of any IVF is linked to many factors, not only biological but also connected to the mean success rate of the fertility center.

For these reasons, the need to find methods for identifying the best gametes and embryos to guarantee a successful pregnancy is becoming pressing. AI can be essential to develop prediction models for pregnancy outcomes for patients undergoing ART treatments.

AI currently represents a modern way to obtain algorithms from a set of observable data that could help clinical decisions

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Diseases

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Claudia Omes, PhD; Phone Number: +390382503238; Email: c.omes@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • SSD Ostetricia e Ginecologia 2 - Fondazione IRCCS Policlinico San Matteo, Pavia
    • Contact: Claudia Omes, PhD; Phone Number: +390382503238; Email: c.omes@smatteo.pv.it
    • Contact: Claudia Omes, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing ART procedures (n= 200, ) at SSD Ostetricia e Ginecologia 2 - PMA of Fondazione IRCCS Policlinico San Matteo, Pavia (Italy)

Description

Inclusion Criteria:

• Women with age below 43 years old
• IVF cycle with fresh semen sample that could be used
• progressive motile spermatozoa expected count of minimum 1 million following density gradient purification on the day of oocyte pick up

Exclusion Criteria:

• Women with uterine abnormalities
• Women with chromosomal and genetic abnormalities
• Positivity to serological test (HCV, HBV, HIV, VDRL-TPHA)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patients with a positive autoimmune panel; Women undergoing ART procedures with a positive autoimmune panel
patients with a negative autoimmune panel; Women undergoing ART procedures with a negative autoimmune panel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive algorithm creation	Probability to achieve a pregnancy	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Collaborators: Università degli Studi di Pavia
• Investigators: Principal Investigator: Claudia Omes, PhD, Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: AI-IVF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No