Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases

NCT ID: NCT05807256

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2025-11-30

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.

Detailed Description

According to standard clinical practice related to medically assisted procreation treatments, for controlled ovarian stimulation aimed at oocyte recovery, patients underwent therapy with recombinant, biosimilar, or purified human gonadotropins and eventual suppression of spontaneous ovulation with gonadotropin-releasing hormone stimulating antagonist (gnRH-antagonist), and this information will therefore be recorded. The subsequent final induction of oocyte maturity can be by purified human chorionic gonadotropin (hCG), by gonadotropin-releasing hormone stimulating hormone analog (GnRHa), or by the combination of the two, and this information will therefore also be recorded. Similarly, therapies routinely administered for endometrial preparation and luteal support during embryo transfer procedures will also be recorded (transdermal estradiol, oral estradiol; transvaginal micronized progesterone; subcutaneous progesterone). With regard to the types of PMA used, patients may have undergone homologous or heterologous procedures based on the patient's own choice and specialist indications. The IVF technique is an in vitro fertilization that consists of the union of the egg with the sperm in the laboratory -in vitro- for the purpose of obtaining already fertilized embryos to be transferred into the maternal uterus. The ICSI technique consists of intracytoplasmic sperm injection and involves the insemination of an oocyte by micro-injection of a single sperm directly into it.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

pregnant patients with systemic rheumatological diseases

pregnant patients with systemic rheumatological diseases undergoing assisted fertilization techniques

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

Intervention Type: 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.

Interventions

collection 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Rovere Querini Patrizia

Associate Professor of Internal Medicine, Vita-Salute San Raffaele University Head physician, U.O. General Medicine and Continuity of Care, IRCCS San Raffaele Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrizia Rovere Querini, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Locations

San Raffaele Hospital

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Patrizia Rovere Querini, PhD, MD

Role: CONTACT

rovere.patrizia@hsr.it

+390226436095

Valentina Canti, MD

Role: CONTACT

canti.valentina@hsr.it

+390226436095

Facility Contacts

Patrizia Rovere Querini, PhD,MD

Role: primary

rovere.patrizia@hsr.it

+390226433065

Valentina Canti, MD

Role: backup

canti.valentina@hsr.it

+390226436095

Other Identifiers

PMA_AD

Identifier Type: -

Identifier Source: org_study_id