Fertility Study of Women With Chronic Inflammatory Rheumatism

• Conditions: Arthritis, Rheumatoid; Chronic Juvenile Arthritis; Ankylosing Spondylitis; Arthritis, Psoriatic

• Registration Number: NCT03452735
• Lead Sponsor: University Hospital, Toulouse

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.

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 Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-02
• Status Verified: 2018-07
• Study Start: 2018-07-16
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2900

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Birth rate after spontaneous or induced pregnancy	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

Name	Time	Method
Birth rate according to the treatments used	One day	Birth rate in the CIR group according to the treatments used
Rates of ectopic pregnancy, early or late spontaneous miscarriage	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
Rates of desire for pregnancy	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
Design time	One day	Design time in the CIR group and in the control group
Birth rate according to the activity of the disease	One day	Birth rate in the CIR group according to the activity of the disease
Rates of sexual dysfunction	One day	Rates of sexual dysfunction in the CIR group and in the control group

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France