Rheumatoid Arthritis Clinical Trial
Official title:
Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis
Verified date | April 2017 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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 |
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