Evaluating Fertility Treatments in Women with Rheumatic Diseases
Assessment of Maternal-fetal Outcome in Pregnancy From Medically Assisted Fertilization Techniques in Women With Systemic Immunoreumatologic Diseases
IRCCS San Raffaele · NCT05807256
This study is trying to see how well fertility treatments work for women with rheumatic diseases and if these treatments affect their health conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT05807256 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there is limited data on similar studies, the approach of evaluating ART outcomes in patients with rheumatic diseases is relatively novel and underexplored.
Eligibility criteria
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 this trial is running
Milan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rheumatic Diseases, Fertility Disorders, Pregnancy, High Risk, Pregnancy Complications, Immunologic Disease