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Ovarian Reserve in Patients With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03492632
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Psoriasis Anti Mullerian Hormone Ovarian Reserve Other: Hormone panel

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
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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Ovarian Reserve in Patients With Psoriasis
Actual Study Start Date : October 25, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Psoriasis

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
Blood samples for the measurement of serum FSH,LH,E2,PRL and AMH

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492632


Locations
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Turkey
Kanuni Sultan Suleyman Research and Training Hospital
Istanbul, Turkey, 34303
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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Principal Investigator: Berna Aslan Cetin, MD Kanuni Sultan Suleyman Research and Training Hospital
More Information
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Responsible Party: Berna Aslan Cetin, Principle investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03492632    
Other Study ID Numbers: 2017/325
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital:
psoriasis
Anti mullerian hormone
ovarian reserve
antral follicle count
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs