Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis

Duke University

Status: Completed

Conditions: Infertility; Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT02313129

Pro00057614

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

150 participants in 2 patient groups

Rheumatoid Arthritis

Description:

This group will complete questionnaires related to prior pregnancies, intentions and goals for childbearing, fertility history and detailed menstrual history. They will also have a physical exam and blood tests.

Healthy Controls

Description:

This group will complete questionnaires related to prior pregnancies, intentions and goals for childbearing, fertility history detailed menstrual history, and blood tests.