NCT02094313

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

6 years

First QC Date

March 17, 2014

Last Update Submit

March 20, 2014

Conditions

Healthy VolunteersNormocholesterolaemic MenNormozoospermic Men

Keywords

AtorvastatinHuman SpermatozoaSeminal fluidAccessory GlandsCholesterolGonadotropins,Testosterone

Outcome Measures

Primary Outcomes (2)

  • Observations of all modifications on semen quality after 5 months of atorvastatin treatment

    at month 5

  • Observations of all modifications on semen quality after 5 months of atorvastatin treatment and after 3 months after its withdrawal

    at month 8

Secondary Outcomes (4)

  • hormonal profile: gonadotropins and total testosterone plasma levels

    at month 5

  • lipid composition of sperm and seminal fluid

    at month 5

  • spermatozoa capacitation markers

    at month 5

  • accessory glands markers

    at month 5

Study Arms (1)

atovastatin

EXPERIMENTAL
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

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.

Also known as: cholesterol lowering drug
atovastatin

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Pons-Rejraji H, Brugnon F, Sion B, Maqdasy S, Gouby G, Pereira B, Marceau G, Gremeau AS, Drevet J, Grizard G, Janny L, Tauveron I. Evaluation of atorvastatin efficacy and toxicity on spermatozoa, accessory glands and gonadal hormones of healthy men: a pilot prospective clinical trial. Reprod Biol Endocrinol. 2014 Jul 12;12:65. doi: 10.1186/1477-7827-12-65.

    PMID: 25016482DERIVED

MeSH Terms

Interventions

AtorvastatinAnticholesteremic Agents

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesLipid Regulating AgentsTherapeutic Uses

Study Officials

  • Igor TAUVERON

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 21, 2014

Study Start

January 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

FR(1)