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Fertility Study of Women With Chronic Inflammatory Rheumatism (FERTIRHUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452735
Recruitment Status : Unknown
Verified July 2018 by University Hospital, Toulouse.
Recruitment status was:  Recruiting
First Posted : March 2, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Arthritis, Psoriatic Arthritis, Rheumatoid Ankylosing Spondylitis Chronic Juvenile Arthritis Other: Questionnaire about fertility

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
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Study Type : Observational
Estimated Enrollment : 2900 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Fertility Study of Women With Chronic Inflammatory Rheumatism
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Other: Questionnaire about fertility
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.
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
 Other: Questionnaire about fertility
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rates of ectopic pregnancy, early or late spontaneous miscarriage [ Time Frame: one day ]
    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

  2. Design time [ Time Frame: One day ]
    Design time in the CIR group and in the control group

  3. Birth rate according to the treatments used [ Time Frame: One day ]
    Birth rate in the CIR group according to the treatments used

  4. Birth rate according to the activity of the disease [ Time Frame: One day ]
    Birth rate in the CIR group according to the activity of the disease

  5. Rates of desire for pregnancy [ Time Frame: One day ]
    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

  6. Rates of sexual dysfunction [ Time Frame: One day ]
    Rates of sexual dysfunction in the CIR group and in the control group


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   study on woman fertility
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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 ...)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient> 40 years old at the time of diagnosis
  • Patient with insufficient medical data (treatments)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452735


Contacts
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Contact: Jean Parinaud, MD 5 67 77 11 02 ext 33 parinaud.j@chu-toulouse.fr
Contact: Isabelle Olivier, PhD 5 61 77 70 51 ext 33 olivier.i@chu-toulouse.fr

Locations
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France
University Hospital Toulouse Recruiting
Toulouse, France, 31059
Contact: Jean Parinaud, MD    05 67 77 10 02 ext 33    parinaud.j@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Jean Parinaud, MD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03452735    
Other Study ID Numbers: RC31/17/0446
2017-A03539-44 ( Other Identifier: ID-RCB )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Chronic inflammatory rheumatism
Fertility
Procreation
Additional relevant MeSH terms:
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Spondylitis
Rheumatic Fever
Arthritis
Spondylitis, Ankylosing
Arthritis, Rheumatoid
Rheumatic Diseases
Arthritis, Psoriatic
Arthritis, Juvenile
Collagen Diseases
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infections
Bone Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses