NCT05807256

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-05-04
• Primary completion: 2025-10-30
• Completion: 2025-11-30
• First posted: 2023-04-11
• Last updated: 2025-06-18

Locations

1 site across 1 country: Italy