Ovarian Reserve in Patients With Psoriasis

July 3, 2018 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34303
        • Kanuni Sultan Süleyman Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with Psoriasis
Reproductive age women newly diagnosed with psoriasis
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.
Women without Psoriasis
Reproductive age women without psoriasis to serve as control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Berna Aslan Cetin, MD, Kanuni Sultan Süleyman Research and Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

July 3, 2018

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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