Treament of impaired sperm quality with micronutrients

ISRCTN ISRCTN48594239
DOI https://doi.org/10.1186/ISRCTN48594239
Secondary identifying numbers Sperm parameter protocol 1.03/2014
Submission date
14/08/2016
Registration date
07/10/2016
Last edited
12/12/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Markus Lipovac
Public

Wiener Ring 3-5
Korneuburg
2100
Austria

ORCiD logoORCID ID 0000-0003-3583-6601
Prof Martin Imhof
Scientific

Wiener Ring 3-5
Korneuburg
2100
Austria

Study information

Study designDouble-centre prospective open-labelled non-randomized study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet.
Scientific titleComparison of the effect of a combination of eight micronutrients versus a standard mono preparation on sperm parameters
Study objectivesTo 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(s)Local ethics board of the General Teaching Hospital Korneuburg, Austria, 14/12/2004, No.5/2004
Health condition(s) or problem(s) studiedReduced reproductive capability in men presenting an unexplained (unidentified) abnormal semen analysis
InterventionA 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 typeSupplement
Primary outcome measureThe 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 measuresN/A
Overall study start date11/01/2004
Completion date20/01/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants280
Key inclusion criteria1. 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
Key exclusion criteria1. Azoospermia
2. Aspermia
3. Varicocele
4. Recent urogenital infections
5. Hormonal disorders.
Date of first enrolment11/01/2004
Date of final enrolment15/10/2013

Locations

Countries of recruitment

  • Austria

Study participating centres

IMI Kinderwunschklinik
Dorotheergasse 7
Vienna
1010
Austria
Med 19 Study Center of Vienna
Grinzingerstrasse 83
Vienna
1190
Austria

Sponsor information

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

Wiener Ring 3-5
Korneuburg
2100
Austria

ROR logo "ROR" https://ror.org/05r0e4p82

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2016 Yes No

Editorial Notes

12/12/2016: Publication reference added.