Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02313129

Enrollment

150

Registered

2014-12-09

Start date

2015-08-31

Completion date

2017-01-24

Last updated

2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Rheumatoid Arthritis

Keywords

Infertility, Rheumatoid Arthritis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Ovarian Reserve between women with and without RA	At study enrollment
Ovulation Frequency between women with and without RA	At study enrollment

Secondary

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

Countries

United States

Outcome results