InfertilityNCT02313129
Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis
An observational study of Infertility and Rheumatoid Arthritis, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Rheumatoid Arthritis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 24 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Rheumatoid Arthritis Women and Health Control Women
Who may be able to join
- RA cohort: Women diagnosed with RA (2010 ACR/EULAR criteria) at least one year prior to enrollment
- Healthy cohort: Women without autoimmune disease
Who cannot join
- Unilateral or bilateral ovarian surgery
- Prior exposure to known or possible ovary-toxic medications (e.g., cyclophosphamide, other chemotherapeutic agents)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Infertility, Rheumatoid Arthritis
- Keywords
- Infertility, Rheumatoid Arthritis
- Medical subject headings
- Infertility, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Ovarian Reserve between women with and without RA
Measured: At study enrollment
Ovulation Frequency between women with and without RA
Measured: At study enrollment
Secondary outcomes (3)
Rates of Infertility between women with and without RA
Measured: At study enrollment
Number of Pregnancies between women with and without RA
Measured: At study enrollment
Age at attempted and actual conception between women with and without RA
Measured: At study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startAug 2015
- Primary completion24 Jan 2017
- Study completion24 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Clowse, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313129
- Sponsor's protocol ID
- Pro00057614
- Status last verified
- Apr 2017
- First submitted
- 5 Dec 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02313129
- Acronym / sponsor ID
- Pro00057614
- Conditions
- Infertility, Rheumatoid Arthritis
- Keywords
- Infertility, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 24 Jan 2017 (actual)
- Study completion
- 24 Jan 2017 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Rheumatoid Arthritis Women and Health Control Women
Key inclusion criteria (2 listed)
- RA cohort: Women diagnosed with RA (2010 ACR/EULAR criteria) at least one year prior to enrollment
- Healthy cohort: Women without autoimmune disease
Key exclusion criteria (2 listed)
- Unilateral or bilateral ovarian surgery
- Prior exposure to known or possible ovary-toxic medications (e.g., cyclophosphamide, other chemotherapeutic agents)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ovarian Reserve between women with and without RA
Time frame: At study enrollment
Ovulation Frequency between women with and without RA
Time frame: At study enrollment
3 secondary outcomes
Rates of Infertility between women with and without RA
Time frame: At study enrollment
Number of Pregnancies between women with and without RA
Time frame: At study enrollment
Age at attempted and actual conception between women with and without RA
Time frame: At study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Clowse, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Rheumatoid Arthritis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian Reserve between women with and without RA (time frame: At study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.