Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313129
• Other study ID #: Pro00057614
• Status: Completed
• Phase: N/A
• First received: December 5, 2014
• Last updated: May 3, 2017
• Start date: August 2015
• Est. completion date: January 24, 2017

Study information

• Verified date: April 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to increase our understanding of infertility in women with Rheumatoid Arthritis (RA). In this study the study team will compare the differences in ovarian reserve (the ability to provide egg cells that are capable of fertilization), the frequency of ovulation and the number of pregnancies between women with and without RA. It is possible that RA activity and medications limit ovarian reserve and ovulation, which may increase infertility among women with RA. There are several suspected causes for infertility in RA, including age-related fertility decline, inflammatory changes that impact endometrial receptivity and discourage implantation, accelerated ovarian decline due to certain arthritis medications and increased frequency of anovulation (a menstrual cycle during which ovaries do not release an egg) due to RA activity.

This study is the first step toward our long term goal of increasing the ability of all women with RA to build the family they desire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 24, 2017
• Est. primary completion date: January 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. RA cohort: Women diagnosed with RA (2010 ACR/EULAR criteria) at least one year prior to enrollment

2. Healthy cohort: Women without autoimmune disease

Exclusion Criteria:

1. Unilateral or bilateral ovarian surgery

2. Prior exposure to known or possible ovary-toxic medications (e.g., cyclophosphamide, other chemotherapeutic agents)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Infertility
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian Reserve between women with and without RA		At study enrollment
Primary	Ovulation Frequency between women with and without RA		At study enrollment
Secondary	Rates of Infertility between women with and without RA		At study enrollment
Secondary	Number of Pregnancies between women with and without RA		At study enrollment
Secondary	Age at attempted and actual conception between women with and without RA		At study enrollment