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Recruiting

NCT Number: NCT06872294

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

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

Recruiting

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Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Claudia Omes, PhD

CONTACT

[email protected]

+390382503238

Claudia Omes, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Predictive algorithm creation

    Time frame: through study completion, an average of 2 years

    Probability to achieve a pregnancy

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Omes, PhD

CONTACT

[email protected]

+390382503238

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • University of Pavia

Registry information

Official study title

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

Acronym: AI-IVF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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