Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases

NCT05807256 | Recruiting

• 1 other identifier: PMA_AD
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• To quantify the risk of flare-ups of underlying immunoreumatologic disease and possible occurrence of complications during the procedure or during PMA pregnancies.

  Disease flare-up will be assessed by measuring clinical parameters and antibody values ANA, ENA, SSA\_SSB, antiDNA (U.A.), PMA, post PMA, post pregnancy complement. Complications will be evaluated in terms of maternal/fetal outcome such as hypertension, preeclmpsia, thrombotic events, renal failure, disease flare during pregnancy.

  Within six months after the end of the study

• To quantify the risk of flare-ups of underlying immunoreumatologic disease and possible occurrence of complications during the procedure or during PMA pregnancies.

  Disease flare-up will be assessed by measuring clinical parameters and antibody values, MB2GPI, GB2GPI (UA/mL), PMA, post PMA, post pregnancy complement. Complications will be evaluated in terms of maternal/fetal outcome such as hypertension, preeclmpsia, thrombotic events, renal failure, disease flare during pregnancy.

  Within six months after the end of the study

• To quantify the risk of flare-ups of underlying immunoreumatologic disease and possible occurrence of complications during the procedure or during PMA pregnancies.

  Disease flare-up will be assessed by measuring clinical parameters and antibody values, LAC (Microun./mL), PMA, post PMA, post pregnancy complement. Complications will be evaluated in terms of maternal/fetal outcome such as hypertension, preeclmpsia, thrombotic events, renal failure, disease flare during pregnancy.

  Within six months after the end of the study

• To quantify the risk of flare-ups of underlying immunoreumatologic disease and possible occurrence of complications during the procedure or during PMA pregnancies.

  Disease flare-up will be assessed by measuring clinical parameters and antibody values MACA, GACA, (GPL/MPL/APL unità) PMA, post PMA, post pregnancy complement. Complications will be evaluated in terms of maternal/fetal outcome such as hypertension, preeclmpsia, thrombotic events, renal failure, disease flare during pregnancy.

  Within six months after the end of the study

Study Arms (1)

pregnant patients with systemic rheumatological diseases

pregnant patients with systemic rheumatological diseases undergoing assisted fertilization techniques

Other: collection and analysis of treatments and procedures already performed by normal clinical practice

Interventions

collection and analysis of treatments and procedures already performed by normal clinical practice OTHER

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.

pregnant patients with systemic rheumatological diseases

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 500 women with a definite diagnosis of systemic immunoreumatologic disease according to the criteria classificatory in place in normal clinical practice who underwent one or more PMAs between January 2000 and April 2021 will be enrolled from all participating centers. Pathologies examined will be: APS defined according to Sapporo criteria, SLE, AR, SpA, SScl, SS, PM-DM, systemic vasculitis of large- and small-medium caliber defined according to EULAR/ACR criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Rheumatic Diseases; Pregnancy Complications; Immune System Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Patrizia Rovere Querini, PhD, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia Rovere Querini, PhD, MD

CONTACT

+390226436095; rovere.patrizia@hsr.it

Valentina Canti, MD

CONTACT

+390226436095; canti.valentina@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine, Vita-Salute San Raffaele University Head physician, U.O. General Medicine and Continuity of Care, IRCCS San Raffaele Hospital

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 11, 2023
• Study Start: May 4, 2022
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

IT (1)