Rheumatologic DiseasesNCT02273869
Assessment of Ovarian Reserve in Women With Rheumatologic Diseases
An observational study of Rheumatologic Diseases and Ovarian Reserve, run by Meir Medical Center at 1 site in Israel.
Trial summary
Our infertility unit has started a clinic for women with rheumatological diseases. those women are prone to infertility problems and it might be due to their illness or cytotoxic treatment . In our study we are going to observe the effect of their disease on ovarian reserve. Read more about this study
- Who is it for?
- Ages 12 to 45 years, women only
- Conditions the study is for
- Rheumatologic Diseases, Ovarian Reserve, Infertility
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Apr 2018
- 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 12 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women in reproductive age with rheumatoligic disease
Who may be able to join
- Rheumatologic disease
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Rheumatologic Diseases on Fertility and Ovarian Reserve
Our infertility unit has started a clinic for women with rheumatological diseases. those women are prone to infertility problems and it might be due to their illness or cytotoxic treatment . In our study we are going to observe the effect of their disease on ovarian reserve. we will assess it by using intravaginal sonography and blood test such as hormonal profile and anti-mullerian hormone (AMH).
- Conditions
- Rheumatologic Diseases, Ovarian Reserve, Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
hormone profile
Assessment of ovarian function using hormone profile and AMH levels in serum, in women with rheumatologic disease.
Measured: 4 years
antral follicular count
we will use sonography to assess the antral follicular count as a parameter for ovarian reserve in women with rheumatologic disease.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatologic DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273869
- Sponsor's protocol ID
- MMC-011413-CTIL
- Status last verified
- Sep 2014
- First submitted
- 29 Sep 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Rheumatologic Diseases on Fertility and Ovarian Reserve
- ClinicalTrials.gov ID
- NCT02273869
- Acronym / sponsor ID
- MMC-011413-CTIL
- Conditions
- Rheumatologic Diseases, Ovarian Reserve, Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 24 Oct 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.
Our infertility unit has started a clinic for women with rheumatological diseases. those women are prone to infertility problems and it might be due to their illness or cytotoxic treatment . In our study we are going to observe the effect of their disease on ovarian reserve. we will assess it by using intravaginal sonography and blood test such as hormonal profile and anti-mullerian hormone (AMH).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women in reproductive age with rheumatoligic disease
Key inclusion criteria (1 listed)
- Rheumatologic disease
Key exclusion criteria (1 listed)
- none
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
hormone profile
Time frame: 4 years
Assessment of ovarian function using hormone profile and AMH levels in serum, in women with rheumatologic disease.
antral follicular count
Time frame: 4 years
we will use sonography to assess the antral follicular count as a parameter for ovarian reserve in women with rheumatologic disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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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.
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 Rheumatologic Diseases and Ovarian Reserve, run by Meir Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Einat Haikin HErzberger, M.D (972-506728987, einatcha1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hormone profile (time frame: 4 years). 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 24 Oct 2014.