Effects of Atorvastatin on Human Semen and Gonadal Hormones

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Interest of Clomiphene Citrate in Patients With Non-obstructive Azoospermia on the Quantity of Sperm Cells

NCT03615547

Azoospermia, Nonobstructive

NOT_YET_RECRUITING PHASE3

Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism

NCT02137265

Non Obstructive Azoospermia Hypogonadism

WITHDRAWN NA

Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia.

NCT02900105

Azoospermia, Nonobstructive Oligozoospermia

COMPLETED PHASE3

Aromatase Inhibitors in the Treatment of Male Infertility

NCT00440180

Obesity Oligospermia

TERMINATED PHASE3

Estradiol and Testosterone Levels in Seminal Plasma of Men With Non-obstructive Azoospermia

NCT02255396

Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The main objective is to estimate the safety of atorvastatin on fertility of normocholesterolaemic and healthy men (having normal blood lipid profile and normal sperm parameters) by analyzing its effects on sperm parameters: ejaculate volume, sperm count, total and progressive motility, percentage of typical forms.

The secondary objectives are to assess the changes in:

* hormonal profile: gonadotropins and testosterone plasma levels
* lipid composition of sperm and seminal fluid;
* spermatozoa capacitation markers
* accessory glands markers.

The efficacy is estimated by measuring the lipid lowering action of atorvastatin. It is expected a decrease by 20 and 40% of total cholesterol blood and LDL-cholesterol levels, respectively (total cholesterol \<1.5 g / l and LDL-cholesterol \<1g / l).

Considering this protocol as a pilot study to evaluate safety and efficacy, sample size estimation was fixed considering a Fleming design at one stage. These designs with one group and multi-stages (between 1 and 5) can be seen as filtering steps leading to the decision type go/no go. With a type I error a and statistical power (1-β) equals respectively 5% and 90%, n=17 subjects were necessary to reject the hypotheses of minimal (p=0.85) and maximal (p=0.95) acceptable non-toxicity. If 1 subject or more presented a toxicity, the treatment was considered no safe. To measure the evolution of total cholesterol and LDL-cholesterol levels concerning the efficacy, n=17 subjects were necessary to show a minimal paired difference (to be detected) of 0.5 with expected standard-deviation of difference = 0.5, correlation coefficient of 0.5, a= 5% (two-sided) for a power greater than 90% (1-β=97%).

Subjects are included after a screening visit (visit 0), during which routine laboratory biochemical tests are performed, an electrocardiogram is taken, blood pressure, weight and height are measured; physical examination including testis evaluation and semen parameters are analyzed according to WHO standards 1999 .

The subjects take atorvastatin orally (10mg/day (d), Tahor©, Pfizer Laboratory) during 5 months allowing to study atorvastatin effects on human spermatogenesis and epididymal maturation (one cycle requiring approximately 3 months).

Blood and semen parameters were measured :

* before to take atorvastatin treatment (visit 1)
* at the end of the therapy (visit 3)
* and 3 months after the end of treatment, (visit 4) to perform measurements during different cycles of spermatogenesis on a same subject. After two months of treatment, a consultation (visit 2) is realized to ensure good tolerance to treatment and to control treatment efficiency.

Biochemical clinical and semen measurements take before treatment were considered as "control baseline measures".

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers Normocholesterolaemic Men Normozoospermic Men

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

atovastatin

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atorvastatin

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cholesterol lowering drug

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes