CompletedNot Applicable

Weight Loss Impact on Male Fertility

Brazil20 participantsStarted 2019-01-10

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Seminal evaluation

Timeframe: Six months

Seminal evaluation

Timeframe: Six months

Seminal evaluation

Timeframe: Six months

Trial details

NCT IDNCT04186767

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-20

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