Fertility Study of Women With Chronic Inflammatory Rheumatism

Arthritis, Rheumatoid Clinical Trial

— FERTIRHUM  

Official title:

Fertility Study of Women With Chronic Inflammatory Rheumatism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03452735
• Other study ID #: RC31/17/0446
• Secondary ID: 2017-A03539-44
• Status: Recruiting
• Start date: July 16, 2018
• Est. completion date: July 2019

Study information

• Verified date: July 2018
• Source: University Hospital, Toulouse
• Contact: Jean Parinaud, MD
• Phone: 5 67 77 11 02
• Email: parinaud.j[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2900
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Juvenile
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Chronic Juvenile Arthritis
• Collagen Diseases
• Rheumatic Diseases
• Rheumatic Fever
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One day
Secondary	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	one day
Secondary	Design time	Design time in the CIR group and in the control group	One day
Secondary	Birth rate according to the treatments used	Birth rate in the CIR group according to the treatments used	One day
Secondary	Birth rate according to the activity of the disease	Birth rate in the CIR group according to the activity of the disease	One day
Secondary	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	One day
Secondary	Rates of sexual dysfunction	Rates of sexual dysfunction in the CIR group and in the control group	One day