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Effects of Gonadotropin Replacement Therapy on Metabolic Parameters in Patients With Hypogonadism

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ClinicalTrials.gov Identifier: NCT02728440
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Aydogan Aydogdu, Gulhane School of Medicine

Study Description
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Brief Summary:
Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of Patients with Idiopathic Hypogonadotropic Hypogonadism

Condition or disease Intervention/treatment
Idiopathic Hypogonadotropic Hypogonadism Drug: human chorionic gonadotropin, human menopausal gonadotropin

Detailed Description:
30 male patients diagnosed with IHH and a control group of 20 healthy cases with similar age and BMI were included in the study. The levels of advanced oxidation protein products (AOPP), thiol, malondialdehyde (MDA), nitric oxide (NO) and 8-hydroxydeoxyguanosine (8-OHdG) and the levels of triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-K), low density lipoprotein (LDL-K), Apolipoprotein A1 (ApoA1) and Apolipoprotein B100 (ApoB100) were measured before and after gonadotrophin therapy.
Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Lipid Profile and Oxidative Stress Parameters of Patients With Idiopathic Hypogonadotropic Hypogonadism and the Change of These Parameters With Gonadotropin Replacement Therapy
Study Start Date : May 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Hypogonadotropic hypogonadism patients
30 patients with idiopathic hypogonadotrophic hypogonadism
 Drug: human chorionic gonadotropin, human menopausal gonadotropin
drug for the treatment of male hypogonadism
Other Names:
  • Pregnyl ® Organon hCG 1500 IU
  • Merional ® ARIS 75 IU


Outcome Measures
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Primary Outcome Measures :
  1. oxidative stress after hCG and HMG treatment [ Time Frame: 2010-2012 ]
  2. HDL levels after hCG treatment [ Time Frame: 2010-2012 ]
  3. total cholesterole levels after hCG treatment [ Time Frame: 2010-2012 ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Idiopathic Hypogonadotropic Hypogonadism and healthy control group
Criteria

Inclusion Criteria:

Serum testosterone concentration < 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -

Exclusion Criteria:

diabetes mellitus, arterial hypertension other hormone deficiencies

-

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Aydogan Aydogdu, MD, Gulhane School of Medicine
ClinicalTrials.gov Identifier: NCT02728440    
Other Study ID Numbers: FB03232016
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin
Menotropins
 Reproductive Control Agents
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents