Fertility Study of Women With Chronic Inflammatory Rheumatism

NCT ID: NCT03452735

Last Updated: 2018-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-16

Study Completion Date

2019-07-31

Brief Summary

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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

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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

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Arthritis, Psoriatic Arthritis, Rheumatoid Ankylosing Spondylitis Chronic Juvenile Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Questionnaire about fertility

Intervention Type OTHER

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

Questionnaire about fertility

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Parinaud, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean Parinaud, MD

Role: CONTACT

5 67 77 11 02 ext. 33

Isabelle Olivier, PhD

Role: CONTACT

5 61 77 70 51 ext. 33

Facility Contacts

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Jean Parinaud, MD

Role: primary

05 67 77 10 02 ext. 33

Other Identifiers

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2017-A03539-44

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17/0446

Identifier Type: -

Identifier Source: org_study_id

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