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NCT Number: NCT05807256

Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases

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.

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Key information

Conditions

Rheumatic Diseases Connective Tissue Diseases Female Urogenital Diseases and Pregnancy Complications Fertility Disorders Immune System Diseases Immunologic Disease Musculoskeletal Diseases Pregnancy Complications Pregnancy, High Risk Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Within six months after the end of the study

    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.

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

    Time frame: Within six months after the end of the study

    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.

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

    Time frame: Within six months after the end of the study

    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.

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

    Time frame: Within six months after the end of the study

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrizia Rovere Querini, PhD, MD

CONTACT

[email protected]

+390226436095

Valentina Canti, MD

CONTACT

[email protected]

+390226436095

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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