RecruitingNCT05807256

Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases

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

Sponsor

IRCCS San Raffaele

Enrollment

500 participants

Start Date

May 4, 2022

Study Type

OBSERVATIONAL

Conditions

Pregnancy Complications Fertility Disorders Pregnancy, High Risk Rheumatic Diseases Immunologic Disease

Summary

Systemic rheumatological diseases often occur in young women of childbearing age and can therefore impact fertility. There are diseases, such as arthritis, which present no contraindication to assisted reproductive techniques (ARTs), because there is no influence on the disease itself if the disease activity at conception is stable. On the other hand, patients suffering from connective tissue diseases, primarily Systemic Lupus Erythematosus (SLE) and patients suffering from primary or SLE-related Anti-Phospholipid Antibody Syndrome (APS), deserve more targeted therapies both in the context of ARTs and in the ensuing pregnancy. To evaluate the response to ARTs in patients with systemic rheumatological diseases, both in terms of reactivation of the underlying pathology and in terms of ARTs outcome.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

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 Criteria2

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.

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Interventions

OTHERcollection and analysis of treatments and procedures already performed by normal clinical practice

The patients' anthropometric variables; laboratory test results; PMA techniques (types of fertilization/drugs used for stimulation) and the outcome of the eventual pregnancy (ongoing treatment during the pregnancy itself, development of maternal/fetal complications, such as hypertension, preeclmpsia, thrombotic events, renal failure, disease flare, neonatal outcome) and data on the type of ovarian stimulation drug treatment.