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NCT03492632 Clinical Trial

Ovarian Reserve in Patients With Psoriasis

Psoriasis Clinical Trial

Official title:
Ovarian Reserve in Patients With Psoriasis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03492632
Other study ID # 2017/325
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 25, 2017
Est. completion date July 3, 2018

Study information
Verified date July 2018
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. This study aims to measure serum hormones including FSH,LH,E2,PRL and AMH (indicators of ovarian reserve) in women with and without psoriasis.

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

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date July 3, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Reproductive age group women: 18-40 years

- Women diagnosed with psoriasis (case group)

- Women without psoriasis (control group)

Exclusion Criteria:

- 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Hormone panel
Blood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH,LH,PRL,E2 and AMH hormone levels.

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Research and Training Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary to compare serum AMH levels between the two groups Serum AMH levels will be measured (using ELISA) and compared between the two groups 1 day
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