PsoriasisNCT03492632
Ovarian Reserve in Patients With Psoriasis
An observational study of Psoriasis and Anti Mullerian Hormone, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Autoimmune diseases including psoriasis are linked to premature ovarian reserve. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Anti Mullerian Hormone, Ovarian Reserve
- What is being tested?
- Hormone panel
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2017to 3 Jul 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will be reproductive age women diagnosed with psoriasis. The control population will be aged and BMI matched women without psoriasis.
Who may be able to join
- Reproductive age group women: 18-40 years
- Women diagnosed with psoriasis (case group)
- Women without psoriasis (control group)
Who cannot join
- Women with PCOS (polycystic ovary syndrome)
- history of ovarian surgery
- Body mass index (BMI) over 30
- Women with other autoimmune diseases including Hashitomo thyroiditis
- Women with family history of premature ovarian insufficiency (POI)
- Women with infertility
- Psoriasis using systemic drugs including steroids and immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Research and Training Hospital
Istanbul, 34303
About this study
Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Autoimmune diseases including psoriasis are linked to premature ovarian reserve. This study aims to measure serum hormones including FSH,LH,E2,PRL and AMH (indicators of ovarian reserve) in women with and without psoriasis.
Read the detailed description
Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Almost 75% of patients are diagnosed before the age of 40. There is also increased evidence on autoimmune disease and their link to premature ovarian failure.Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH),luteinizing hormone (LH),prolactin (PRL), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients newly diagnosed with psoriasis and to compare them to healthy controls. Serum FSH,LH,E2,PRL and AMH will be measured on the 3rd day of the cycle.The serum hormone levels will be compared between women with psoriasis and women without psoriasis
- Conditions
- Psoriasis, Anti Mullerian Hormone, Ovarian Reserve
- Being tested
- Hormone panel
- Keywords
- psoriasis, Anti mullerian hormone, ovarian reserve, antral follicle count
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone panelOther
Blood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH,LH,PRL,E2 and AMH hormone levels.
| Study group | Role | What they receive |
|---|---|---|
| Women with Psoriasis | Reproductive age women newly diagnosed with psoriasis Receives: Other: Hormone panel | |
| Women without Psoriasis | Reproductive age women without psoriasis to serve as control Receives: Other: Hormone panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare serum AMH levels between the two groups
Serum AMH levels will be measured (using ELISA) and compared between the two groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start25 Oct 2017
- Primary completion30 Jun 2018
- Study completion3 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Berna Aslan Cetin, MD, Principal investigator, Kanuni Sultan Suleyman Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492632
- Sponsor's protocol ID
- 2017/325
- Status last verified
- Jul 2018
- First submitted
- 3 Apr 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Reserve in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT03492632
- Acronym / sponsor ID
- 2017/325
- Conditions
- Psoriasis, Anti Mullerian Hormone, Ovarian Reserve
- Keywords
- psoriasis, Anti mullerian hormone, ovarian reserve, antral follicle count
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- 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.
Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Autoimmune diseases including psoriasis are linked to premature ovarian reserve. This study aims to measure serum hormones including FSH,LH,E2,PRL and AMH (indicators of ovarian reserve) in women with and without psoriasis.
Detailed description
Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Almost 75% of patients are diagnosed before the age of 40. There is also increased evidence on autoimmune disease and their link to premature ovarian failure.Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH),luteinizing hormone (LH),prolactin (PRL), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients newly diagnosed with psoriasis and to compare them to healthy controls. Serum FSH,LH,E2,PRL and AMH will be measured on the 3rd day of the cycle.The serum hormone levels will be compared between women with psoriasis and women without psoriasis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with Psoriasis | – | Other: Hormone panelReproductive age women newly diagnosed with psoriasis |
| Women without Psoriasis | – | Other: Hormone panelReproductive age women without psoriasis to serve as control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be reproductive age women diagnosed with psoriasis. The control population will be aged and BMI matched women without psoriasis.
Key inclusion criteria (3 listed)
- Reproductive age group women: 18-40 years
- Women diagnosed with psoriasis (case group)
- Women without psoriasis (control group)
Key exclusion criteria (7 listed)
- Women with PCOS (polycystic ovary syndrome)
- history of ovarian surgery
- Body mass index (BMI) over 30
- Women with other autoimmune diseases including Hashitomo thyroiditis
- Women with family history of premature ovarian insufficiency (POI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormone panelBlood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH,LH,PRL,E2 and AMH hormone levels. | Other | Women with Psoriasis, Women without Psoriasis |
Primary outcome
to compare serum AMH levels between the two groups
Time frame: 1 day
Serum AMH levels will be measured (using ELISA) and compared between the two groups
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 6 Jul 2018.
- premature ovarian failure in patients with psoriasisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Berna Aslan Cetin, MD principal investigator
Kanuni Sultan Suleyman Research and Training Hospital
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 Psoriasis and Anti Mullerian Hormone, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 6 Jul 2018. 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 Turkey (Türkiye). 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?
to compare serum AMH levels between the two groups (time frame: 1 day). 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 6 Jul 2018.