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Trial record 7 of 1989 for:    infertility AND (woman OR women OR female)

Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02313129
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Infertility Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis
Study Start Date : August 2015
Actual Primary Completion Date : January 24, 2017
Actual Study Completion Date : January 24, 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Ovarian Reserve between women with and without RA [ Time Frame: At study enrollment ]
  2. Ovulation Frequency between women with and without RA [ Time Frame: At study enrollment ]

Secondary Outcome Measures :
  1. Rates of Infertility between women with and without RA [ Time Frame: At study enrollment ]
  2. Number of Pregnancies between women with and without RA [ Time Frame: At study enrollment ]
  3. Age at attempted and actual conception between women with and without RA [ Time Frame: At study enrollment ]

Biospecimen Retention:   Samples With DNA
blood tests


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid Arthritis Women and Health Control Women
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02313129


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Megan Clowse, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02313129     History of Changes
Other Study ID Numbers: Pro00057614
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: April 2017

Keywords provided by Duke University:
Infertility
Rheumatoid Arthritis

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Genital Diseases, Male