Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis

May 3, 2017 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Rheumatoid Arthritis Women and Health Control Women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ovarian Reserve between women with and without RA
Time Frame: At study enrollment
At study enrollment
Ovulation Frequency between women with and without RA
Time Frame: At study enrollment
At study enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Megan Clowse, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

January 24, 2017

Study Completion (Actual)

January 24, 2017

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00057614

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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