Actively Recruiting
Assessment of Maternal-fetal Outcome in Pregnancy From Medically Assisted Fertilization Techniques in Women With Systemic Immunoreumatologic Diseases
Led by IRCCS San Raffaele · Updated on 2025-06-18
500
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of medically assisted fertilization techniques in women with systemic rheumatological diseases, such as Systemic Lupus Erythematosus (SLE) and Anti-Phospholipid Antibody Syndrome (APS). The study aims to evaluate how these treatments impact the underlying disease activity and the outcomes of assisted reproductive techniques (ARTs), particularly in women of childbearing age who might be affected by these conditions. Participants undergo standard ovarian stimulation treatments using various types of gonadotropins and hormone therapies to prepare for egg retrieval. The fertilization process may involve in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Hormonal support is provided during embryo transfer. The study records detailed information about the treatments used and the choices made during the fertility procedures. Throughout the study, researchers will collect data on patients' clinical and laboratory tests, treatment details, and pregnancy outcomes, including any complications or disease flare-ups. The primary focus is to measure the risk of disease reactivation and complications within six months following the assisted reproduction procedures and pregnancies. Participant involvement includes monitoring and follow-ups to assess maternal and fetal health during and after pregnancy.
CONDITIONS
Brief Title
Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with systemic immunoreumatologic diseases such as SLE, APS, RA, SpA, SclS, SS, PM-DM, or vasculitis
- Patients who have undergone one or more medically assisted procreation treatments (PMAs) between January 2000 and April 2021
- Patients who had their last follow-up by February 2022
You will not qualify if you...
- Patients diagnosed with only one organ autoimmunity, such as type 1 diabetes, Hashimoto's thyroiditis, celiac disease, or chronic inflammatory bowel disease without systemic disease
- Patients with severe renal failure
- Patients with significant pulmonary hypertension
- Patients with severe cardiomyopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several months covering pregnancy and post-procedure follow-up
Participants who have undergone medically assisted fertilization procedures as part of routine clinical care are observed for maternal and fetal outcomes, including disease flare-ups and pregnancy complications.
1 to 2 visits depending on timing of data collection from clinical records
Trial Site Locations
Total: 1 location
1
San Raffaele Hospital
Milan, Italy
Actively Recruiting
Research Team
P
Patrizia Rovere Querini, PhD, MD
V
Valentina Canti, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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