NCT03492632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

April 3, 2018

Last Update Submit

July 3, 2018

Conditions

PsoriasisAnti Mullerian HormoneOvarian Reserve

Keywords

psoriasisAnti mullerian hormoneovarian reserveantral follicle count

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Women with Psoriasis

Reproductive age women newly diagnosed with psoriasis

Other: Hormone panel

Women without Psoriasis

Reproductive age women without psoriasis to serve as control

Other: Hormone panel

Interventions

Hormone panelOTHER

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

Women with PsoriasisWomen without Psoriasis

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Reproductive age group women: 18-40 years
  • Women diagnosed with psoriasis (case group)
  • Women without psoriasis (control group)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Research and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for the measurement of serum FSH,LH,E2,PRL and AMH

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Berna Aslan Cetin, MD

    Kanuni Sultan Suleyman Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 10, 2018

Study Start

October 25, 2017

Primary Completion

June 30, 2018

Study Completion

July 3, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)