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OpenTrials
Completed

NCT Number: NCT02313129

Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis

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.

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Key information

Conditions

Infertility Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Genital Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • RA cohort: Women diagnosed with RA (2010 ACR/EULAR criteria) at least one year prior to enrollment
  • Healthy cohort: Women without autoimmune disease

Exclusion criteria

  • Unilateral or bilateral ovarian surgery
  • Prior exposure to known or possible ovary-toxic medications (e.g., cyclophosphamide, other chemotherapeutic agents)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2014
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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