Sexual Maturation in β-Thalassemia Major Patients in Assiut University Hospital

NCT03847558 | Unknown DMC

• 1 other identifier: Assiut Univ Children Hospitals
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

cross sectional study to asses sexual maturation in β-Thalassemia Major patients receiving Iron Chelation Therapy in assuit University Hospital and maintenance of 2ry sexual characters and reproduction

Conditions

β-Thalassemia Major Patients Receiving Chelation Therapy

Outcome Measures

Primary Outcomes (2)

• sexual maturation in patients receiving regular chelation will be compared to patients not receiving chelation helps us to improve quality of life for these patients and have normal sexual life

  The present study will be carried out on previously diagnosed transfusion dependent thalassemia patients under chelation therapy in Assiut University children hospital. 1. patients will be selected and examined clinically to asses thier sexual maturation by measuring presence of secondary sexual characters. 2. hormonal assesment for patients including FSH,LH,Serum Testosterone.

  1 year

• calculate body mass index (kg/m^2)

  assesment of hieght in meters,weight in kilograms.

  1 year

Study Arms (1)

sexual maturation in patient receiving iron chelation

assess of sexual maturation by clinical examination and hormonal studies (FSH.LH,Testosterone)

Diagnostic Test: FSH((Follicle Stimulating Hormone) and LH (Luteinizing Hormone) hormone for females and Testosterone hormone for males

Interventions

FSH((Follicle Stimulating Hormone) and LH (Luteinizing Hormone) hormone for females and Testosterone hormone for males DIAGNOSTIC_TEST

assess of sexual maturation by clinical examination and hormonal studies (FSH.LH,Testosterone)

sexual maturation in patient receiving iron chelation

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

β-thalassemic Patients aged 10 years and older patients receiving regular blood transfusions in Assiut Univ Hospitals and have chelation therapy.

You may qualify if:

• β-thalassemic Patients aged 10 years and older
• β-thalassemic patients receiving regular blood transfusions
• All patients are on chelation therapy

You may not qualify if:

• β-thalassemic patients with major system complications as cardiac ,renal or hepatic.
• Patients not receiving chelation therapy
• Patients with other hemolytic anemia

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: February 20, 2019
• Study Start: April 15, 2019
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: February 20, 2019

Record last verified: 2019-02