Rheumatic DiseasesNCT05807256
Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases
An observational study of Rheumatic Diseases and Fertility Disorders, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Rheumatic Diseases, Fertility Disorders, Pregnancy, High Risk
- What is being tested?
- collection and analysis of treatments and procedures already performed by normal clinical practice
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2022to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Hospital
Milan
Patrizia Rovere Querini, PhD,MD, +390226433065, rovere.patrizia@hsr.it
Valentina Canti, MD, +390226436095, canti.valentina@hsr.it
About this study
Official title: Assessment of Maternal-fetal Outcome in Pregnancy From Medically Assisted Fertilization Techniques in Women With 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.
Read the 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
- Being tested
- collection and analysis of treatments and procedures already performed by normal clinical practice
- Medical subject headings
- Rheumatic Diseases, Pregnancy Complications, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection and analysis of treatments and procedures already performed by normal clinical practiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| pregnant patients with systemic rheumatological diseases | pregnant patients with systemic rheumatological diseases undergoing assisted fertilization techniques Receives: Other: collection and analysis of treatments and procedures already performed by normal clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within six months after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start4 May 2022
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rovere Querini Patrizia, IRCCS San Raffaele
- Investigators
- Patrizia Rovere Querini, PhD, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807256
- Sponsor's protocol ID
- PMA_AD
- Status last verified
- Jun 2025
- First submitted
- 15 Mar 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maternal-fetal Outcome in Pregnancy From Medically Assisted Fertilization Techniques in Women With Systemic Immunoreumatologic Diseases
- ClinicalTrials.gov ID
- NCT05807256
- Acronym / sponsor ID
- PMA_AD
- Conditions
- Rheumatic Diseases, Fertility Disorders, Pregnancy, High Risk, Pregnancy Complications, Immunologic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant patients with systemic rheumatological diseases | – | Other: collection and analysis of treatments and procedures already performed by normal clinical practicepregnant patients with systemic rheumatological diseases undergoing assisted fertilization techniques |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection and analysis of treatments and procedures already performed by normal clinical practiceThe 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. | Other | pregnant patients with systemic rheumatological diseases |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrizia Rovere Querini, PhD, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases and Fertility Disorders, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrizia Rovere Querini, PhD, MD (+390226436095, rovere.patrizia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.