Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis

Completed

• Conditions: Infertility; Rheumatoid Arthritis

• Registration Number: NCT02313129
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Study Start: 2015-08
• Primary Completion: 2017-01-24
• Study Completion: 2017-01-24
• Status Verified: 2017-04
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ovarian Reserve between women with and without RA	At study enrollment
Ovulation Frequency between women with and without RA	At study enrollment

Secondary Outcome Measures

Name	Time	Method
Number of Pregnancies between women with and without RA	At study enrollment
Rates of Infertility between women with and without RA	At study enrollment
Age at attempted and actual conception between women with and without RA	At study enrollment

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States