Arthritis, PsoriaticFERTIRHUMNCT03452735
Fertility Study of Women With Chronic Inflammatory Rheumatism
An observational study of Arthritis, Psoriatic and Arthritis, Rheumatoid, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Etiopathogenesis of Chronic inflammatory rheumatisms (CIR) includes genetic, autoimmune and environmental factors. Their impact on the quality of life is important, leading to a sometimes severe disability. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Ankylosing Spondylitis
- What is being tested?
- Questionnaire about fertility
- How many people
- 2,900 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2018to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Study population: * Case group: patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis * Control Group: patient not suffering from RIC, having consulted in rheumatology for a mechanical pathology (eg osteoarthritis, mechanical low back pain ...)
Who may be able to join
- Patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism
- Patient diagnosed before the age of 40
- Patient having given her no opposition to her participation in research
- For the control group: patient not suffering from chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology
Who cannot join
- Patient> 40 years old at the time of diagnosis
- Patient with insufficient medical data (treatments)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Jean Parinaud, MD, 05 67 77 10 02 ext. 33, parinaud.j@chu-toulouse.fr
About this study
Etiopathogenesis of Chronic inflammatory rheumatisms (CIR) includes genetic, autoimmune and environmental factors. Their impact on the quality of life is important, leading to a sometimes severe disability. Thus they are likely to affect female fertility through several mechanisms, including autoimmune since the association between immunity and fertility has already been demonstrated in other autoimmune diseases.
This study wants to evaluate and compare the birth rate between CIR and control group.
Read the detailed description
Data collection will be carried out using a questionnaire submitted to women in charge of the rheumatology department of the University Hospital of Toulouse and having agreed to participate:
- women with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis or Chronic juvenile arthritis for the chronic inflammatory rheumatism group
- women with a mechanical rheumatic pathology for the control group
The primary endpoint was birth rate after spontaneous or induced pregnancy in patients who attempted to procreate, in the CIR group and in the control group.
- Conditions
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Ankylosing Spondylitis, Chronic Juvenile Arthritis
- Being tested
- Questionnaire about fertility
- Keywords
- Chronic inflammatory rheumatism, Fertility, Procreation
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about fertilityOther
Sending a questionnaire about fertility that will have to be returned to us in order to be included in the study. The questionnaires, anonymous, will be numbered according to their order of return.
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed before age 40 | Patient between 18 and 50 years-old with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism who will answer to a questionnaire about fertility Receives: Other: Questionnaire about fertility | |
| Control Group | Patient between the ages of 18 and 50 years, not diagnosed with Chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology, presenting no chronic pathology, having no chemo or radiotherapy or immunosuppressive therapy, or pelvic surgery before age 40 years who will answer to a questionnaire about fertility Receives: Other: Questionnaire about fertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth rate after spontaneous or induced pregnancy
Birth rate after spontaneous or induced pregnancy in women who have tried to procreate in the chronic inflammatory rheumatism group and in the control group.
Measured: One day
Secondary outcomes (6)
Rates of ectopic pregnancy, early or late spontaneous miscarriage
Rates of ectopic pregnancy, early or late spontaneous miscarriage, early or late pregnancy, children born dead, preterm birth in the CIR group and in the control group
Measured: one day
Design time
Design time in the CIR group and in the control group
Measured: One day
Birth rate according to the treatments used
Birth rate in the CIR group according to the treatments used
Measured: One day
Birth rate according to the activity of the disease
Birth rate in the CIR group according to the activity of the disease
Measured: One day
Rates of desire for pregnancy
Rates of desire for pregnancy and study of the reasons for this lack of desire for pregnancy in the CIR group and in the control group
Measured: One day
Rates of sexual dysfunction
Rates of sexual dysfunction in the CIR group and in the control group
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start16 Jul 2018
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Parinaud, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452735
- Sponsor's protocol ID
- RC31/17/0446
- Other IDs
- 2017-A03539-44
- Acronym
- FERTIRHUM
- Status last verified
- Jul 2018
- First submitted
- 26 Feb 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Study of Women With Chronic Inflammatory Rheumatism
- ClinicalTrials.gov ID
- NCT03452735
- Acronym / sponsor ID
- FERTIRHUM / RC31/17/0446
- Conditions
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Ankylosing Spondylitis, Chronic Juvenile Arthritis
- Keywords
- Chronic inflammatory rheumatism, Fertility, Procreation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 2 Mar 2018 (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.
Etiopathogenesis of Chronic inflammatory rheumatisms (CIR) includes genetic, autoimmune and environmental factors. Their impact on the quality of life is important, leading to a sometimes severe disability. Thus they are likely to affect female fertility through several mechanisms, including autoimmune since the association between immunity and fertility has already been demonstrated in other autoimmune diseases.
This study wants to evaluate and compare the birth rate between CIR and control group.
Detailed description
Data collection will be carried out using a questionnaire submitted to women in charge of the rheumatology department of the University Hospital of Toulouse and having agreed to participate:
- women with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis or Chronic juvenile arthritis for the chronic inflammatory rheumatism group
- women with a mechanical rheumatic pathology for the control group
The primary endpoint was birth rate after spontaneous or induced pregnancy in patients who attempted to procreate, in the CIR group and in the control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed before age 40 | – | Other: Questionnaire about fertilityPatient between 18 and 50 years-old with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism who will answer to a questionnaire about fertility |
| Control Group | – | Other: Questionnaire about fertilityPatient between the ages of 18 and 50 years, not diagnosed with Chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology, presenting no chronic pathology, having no chemo or radiotherapy or immunosuppressive therapy, or pelvic surgery before age 40 years who will answer to a questionnaire about fertility |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- * Case group: patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis * Control Group: patient not suffering from RIC, having consulted in rheumatology for a mechanical pathology (eg osteoarthritis, mechanical low back pain ...)
Key inclusion criteria (4 listed)
- Patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism
- Patient diagnosed before the age of 40
- Patient having given her no opposition to her participation in research
- For the control group: patient not suffering from chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology
Key exclusion criteria (2 listed)
- Patient> 40 years old at the time of diagnosis
- Patient with insufficient medical data (treatments)
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 |
|---|---|---|
| Questionnaire about fertilitySending a questionnaire about fertility that will have to be returned to us in order to be included in the study. The questionnaires, anonymous, will be numbered according to their order of return. | Other | Control Group, patients diagnosed before age 40 |
Primary outcome
Birth rate after spontaneous or induced pregnancy
Time frame: One day
Birth rate after spontaneous or induced pregnancy in women who have tried to procreate in the chronic inflammatory rheumatism group and in the control group.
6 secondary outcomes
Rates of ectopic pregnancy, early or late spontaneous miscarriage
Time frame: one day
Design time
Time frame: One day
Birth rate according to the treatments used
Time frame: One day
Birth rate according to the activity of the disease
Time frame: One day
Rates of desire for pregnancy
Time frame: One day
Rates of sexual dysfunction
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean Parinaud, MD principal investigator
University Hospital, Toulouse
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 Arthritis, Psoriatic and Arthritis, Rheumatoid, run by University Hospital, Toulouse at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Jul 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Parinaud, MD (5 67 77 11 02 ext. 33, parinaud.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth rate after spontaneous or induced pregnancy (time frame: One day). 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 23 Jul 2018.