Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases

San Donato Group (GSD)

Status

Enrolling

Conditions

Fertility Disorders

Pregnancy Complications

Immunologic Disease

Pregnancy, High Risk

Rheumatic Diseases

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT05807256

PMA_AD

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.