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Weight Loss Impact on Male Fertility

U

University of Sao Paulo

Status

Completed

Conditions

Sub Fertility, Male
Obesity
Metabolic Syndrome

Treatments

Dietary Supplement: Very Low Carb Ketogenic Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT04186767
86158918.4.0000.0068

Details and patient eligibility

About

This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Patients selected at the endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK) for 6 months, being reassessed clinically and laboratorially monthly.

Enrollment

20 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Obesity in male patients

  • Metabolic Syndrome (NCEP-ATP III)
  • Alteration of some of the seminal parameters evaluated in conventional seminal analysis

Exclusion criteria

  • Other causes of hypogonadotrophic hypogonadism

    • Hypergonadotrophic hypogonadism
    • Contraindications for performance of ketogenic diet:
    • Type 1 or type 2 diabetes mellitus in insulin use
    • Food drive
    • Alcoholism or drug addiction
    • Severe psychiatric illness
    • Use of coumarin anticoagulants
    • Hepatic insufficiency
    • Severe renal impairment
    • Hematologic diseases
    • Cancer in activity,
    • Cardiovascular or cerebrovascular diseases (arrhythmias, recent myocardial infarction, unstable angina, decompensated heart failure, recent stroke)
    • Gout
    • Renal or biliary lithiasis
    • Major depression or other serious psychiatric illness.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Weight loss
Experimental group
Treatment:
Dietary Supplement: Very Low Carb Ketogenic Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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