Weight Loss Impact on Male Fertility

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)

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20 participants in 1 patient group

Weight loss

Experimental group

Treatment:

Dietary Supplement: Very Low Carb Ketogenic Diet