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

NCT ID: NCT06872294

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-22

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Autoimmune Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with a positive autoimmune panel

Women undergoing ART procedures with a positive autoimmune panel

No interventions assigned to this group

patients with a negative autoimmune panel

Women undergoing ART procedures with a negative autoimmune panel

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Pavia

UNKNOWN

Sponsor Role collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Claudia Omes

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Omes, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Policlinico San Matteo di Pavia

Locations

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

Pavia, Pavia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Claudia Omes, PhD

Role: CONTACT

+390382503238

Facility Contacts

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Claudia Omes, PhD

Role: primary

+390382503238

Other Identifiers

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AI-IVF

Identifier Type: -

Identifier Source: org_study_id

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