Effects of Atorvastatin on Human Semen and Gonadal Hormones

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

Recently, concerns about the effect of atorvastatin intake on men fertility have been raised. However, this statin has never been investigated regarding its influence on male fertility, notably sperm quality.

The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of cholesterol blood levels, induced by taking atorvastatin, on sperm quality of normocholesterolaemic and healthy men without confounding factors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: EA 975, Laboratoire de BDR; Laboratoire d'Hormonologie - Biochimie; Laboratoire d’Hormonologie - Biochimie; Service d'Endocrinologie, Diabète et Maladies Métaboliques; Service d’Endocrinologie, Diabète et Maladies Métaboliques; Service de Biologie de la Reproduction : AMP-CECOS
• Treatments: Anticholesteremic Agents; Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Men :

• between 18 and 65 years ;

• with normal conventional semen parameters and negative semen culture according to WHO standards 1999 : volume ejaculate ≥ 2 ml, sperm count ≥ 20millions/ml, total motility ≥ 50% progressive motility ≥ 30%, typical forms ≥ 20%;

• with normal blood lipid profile: total cholesterol < 2.50g/L, triglycerides < 1.70g/L, HDL-C > 0.35 g/L and LDL-C < 2.2 g/L;

• without known pathology or ongoing treatment

Exclusion Criteria:

• Subjects with medical or surgical history that may make them at risk during the study,

• Subjects with cons-indications to taking atorvastatin

• Subjects with an active liver disease or increased level of serum transaminases

• Subjects with a history of allergy

• Subjects whose lipid parameters do not match the inclusions criteria or receiving lipid-lowering therapy

• Subject with abnormal semen analysis or cryptorchidism or a varicocele

• Subjects who participated in another clinical trial or other experimentation or other tolerance study of a drug