Condition category
Urological and Genital Diseases
Date applied
14/08/2016
Date assigned
07/10/2016
Last edited
27/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Infertility is when a couple cannot get pregnant (conceive), despite having regular unprotected sex. 10-15% of reproductive-aged couples trying to achieve pregnancy remain childless. Nearly half of all cases of infertility are due to male infertility. Male infertility is caused by abnormal sperm. In 45% of subfertile or infertile men the cause is unknown. This condition is called idiopathic (oligo)±(atheno)±(terato)spermia (iOAT). There are reports showing that the supplement l-carnitine alone or in combination with other micronutrients improves sperm parameters (i.e., number, movement, shape of sperm). Micronutrients, often referred to as vitamins and minerals, are parts of the diet which are required by the body in small amounts. The aim of this study is to compare the short-term effects of a combination of eight micronutrients including l-carnitine versus l-carnitine alone on sperm parameters as a treatment for iOAT.

Who could participate?
Infertile men aged 20-60

What did the study involve?
Participants are allocated to one of two groups. Participants in group 1 are given l-carnitine twice a day for three months. Participants in group 2 are given a combination of eight micronutrients including l-carnitine once a day for three months. Each participant provides two sperm samples before and then again after the treatment period. The samples are then analysed for sperm count and mobility (how well they move).

What were the possible benefits and risks of participating?
Participants may benefit from improved sperm quality. No side effects are expected.

Where was the study run from?
Karl Landsteiner Institut für zellorientierte Therapie in der Gynäkologie (Austria)

When did the study start and how long did it run?
January 2004 to January 2014

Who was funding the study?
Investigator initiated and funded

Who is the main contact?
1. Prof. Dr Martin Imhof
2. Dr Markus Lipovac

Trial website

Contact information

Type

Public

Primary contact

Dr Markus Lipovac

ORCID ID

http://orcid.org/0000-0003-3583-6601

Contact details

Wiener Ring 3-5
Korneuburg
2100
Austria

Type

Scientific

Additional contact

Prof Martin Imhof

ORCID ID

Contact details

Wiener Ring 3-5
Korneuburg
2100
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sperm parameter protocol 1.03/2014

Study information

Scientific title

Comparison of the effect of a combination of eight micronutrients versus a standard mono preparation on sperm parameters

Acronym

Study hypothesis

To compare the short term effects of a combination of eight micronutrients including l-carnitine vs. a mono-substance (l-carnitine alone) on sperm parameters showing superoirity of the combination over the mono-substance concerning different semen parameters.

Ethics approval

Local ethics board of the General Teaching Hospital Korneuburg, Austria, 14/12/2004, No.5/2004

Study design

Double-centre prospective open-labelled non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.

Condition

Reduced reproductive capability in men presenting an unexplained (unidentified) abnormal semen analysis

Intervention

A total of 299 participants who met the inclusion criteria were invited to participate. Participant number 1 was allocated to group 1, participant number 2 to group 2, participant number 3 to group 1 etc, to receive treatment for three months with:
1. A mono-substance (500 mg l-carnitine/twice a day, n=156)
2. A combined compound (440 mg l-carnitine + 250 mg l-arginine + 40 mg zinc + 120 mg vitamin E + 80 mg glutathione + 60 µg selenium + 15 mg coenzyme Q10 + 800 µg folic acid/once a day, n=143; Profertil®, Lenus Pharma GmbH, Vienna, Austria)
Semen analysis was performed at baseline and after three months of treatment.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

The following sperm parameters were analysed at baseline and after 3 months of treatment:
1. Sperm volume (ml)
2. Sperm density (mio/ml)
3. Overall, fast and slow progressive motility (expressed as %)
4. % of sperm with normal morphology
All parameters were defined according to WHO guidelines (4th edition). Sperm analysis was performed with an automatic, computer analysing system called Sperm Class Analyzer® CASA System, by MICROPTIC SL, company based in Barcelona, Spain.

Secondary outcome measures

N/A

Overall trial start date

11/01/2004

Overall trial end date

20/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. 20 to 60 years of age
3. Suffering from at least one year of subfertility
4. At least one recent pathological semen analysis result

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

280

Participant exclusion criteria

1. Azoospermia
2. Aspermia
3. Varicocele
4. Recent urogenital infections
5. Hormonal disorders.

Recruitment start date

11/01/2004

Recruitment end date

15/10/2013

Locations

Countries of recruitment

Austria

Trial participating centre

IMI Kinderwunschklinik
Dorotheergasse 7
Vienna
1010
Austria

Trial participating centre

Med 19 Study Center of Vienna
Grinzingerstrasse 83
Vienna
1190
Austria

Sponsor information

Organisation

Karl Landsteiner Institute of Cell-Based Treatment in Gynecology (Karl Landsteiner Institut für zellorientierte Therapie in der Gynäkologie)

Sponsor details

Wiener Ring 3-5
Korneuburg
2100
Austria

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Karl Landsteiner Institute of Cell-Based Treatment in Gynecology (Karl Landsteiner Institut für zellorientierte Therapie in der Gynäkologie)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes