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

NCT06872294 | Recruiting

• 1 other identifier: AI-IVF
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• Predictive algorithm creation

  Probability to achieve a pregnancy

  through study completion, an average of 2 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Università degli Studi di Pavia: collaborator

Study Sites (1)

SSD Ostetricia e Ginecologia 2 - Fondazione IRCCS Policlinico San Matteo, Pavia

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Claudia Omes, PhD

  Fondazione IRCCS Policlinico San Matteo di Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Omes, PhD

CONTACT

+390382503238; c.omes@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 12, 2025
• Study Start: November 22, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)