Clinical trial Recruiting at 1 site Observational Ages 18 to 50 Women only

Evaluating Fertility Treatments in Women with Rheumatic Diseases

Official title: Assessment of Maternal-fetal Outcome in Pregnancy From Medically Assisted Fertilization Techniques in Women With Systemic Immunoreumatologic Diseases

Run by IRCCS San Raffaele · NCT05807256 · Data updated 2026-11-12

This study is trying to see how well fertility treatments work for women with rheumatic diseases and if these treatments affect their health conditions.

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Quick facts

Study typeObservational
Ages18 Years to 50 Years
SexWomen only
Enrollment500 (estimated)
SponsorIRCCS San Raffaele
Academic / other
Locations1 site (Milan)
StatusRecruiting
StartedMay 4, 2022
Main results expectedOctober 30, 2025
Study endsNovember 30, 2025
Registry record updatedJune 18, 2025
Trial IDNCT05807256 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women of childbearing age diagnosed with systemic immunoreumatologic diseases who have undergone assisted reproductive techniques between January 2000 and April 2021.

Probably not a fit

Patients with isolated organ autoimmunity or severe comorbidities such as renal failure or significant pulmonary hypertension may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the outcomes of assisted reproductive techniques (ARTs) in women diagnosed with systemic rheumatological diseases, such as Systemic Lupus Erythematosus and Anti-Phospholipid Antibody Syndrome. It will analyze the response to ARTs, focusing on the potential reactivation of underlying diseases and the success rates of fertility treatments. The study will collect data on various fertility treatments administered, including ovarian stimulation and embryo transfer procedures, to understand their impact on both fertility and disease management.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into safe and effective fertility treatments for women with systemic rheumatological diseases.

How similar studies have gone: While there is limited data on similar studies, the approach of evaluating ART outcomes in patients with rheumatic diseases is relatively novel and underexplored.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients diagnosed with systemic immunoreumatologic disease such as SLE, APS, RA, SpA, SclS, SS, PM-DM, vasculitis
* patients who have performed one or more PMAs between January 2000 and April 2021
* patients who had their last follow-up by February 2022

Exclusion Criteria:

* Patients diagnosed with only one organ autoimmunity (e.g., diabetes mellitus I, thyroiditis of Hashimoto's, celiac disease or chronic inflammatory bowel disease in the absence of systemic disease associated);
* patients with severe renal failure, significant pulmonary hypertension or cardiomyopathy severe.

Where it's running

  • San Raffaele Hospital
    Milan, Italy
    Recruiting

Study contacts

  • Principal investigator: Patrizia Rovere Querini, PhD, MD — IRCCS Ospedale San Raffaele
  • Study coordinator: Patrizia Rovere Querini, PhD, MD
  • Email: rovere.patrizia@hsr.it
  • Phone: +390226436095

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.