Condition category
Urological and Genital Diseases
Date applied
19/08/2016
Date assigned
08/09/2016
Last edited
08/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A couple's inability to conceive after 1 year of regular unprotected intercourse clinically defines infertility, a condition which affects approximately 15% of the reproductive-aged population. Over half of all cases are at least partly due to make fertility problems and up to 40% is due to male fertility problems alone. Male infertility is often linked to abnormalities apparent when the semen is examined. About one third of infertile men are affected by a condition called idiopathic (oligo)±(atheno)±(terato) spermia (iOAT): which occurs despite no evidence of any clinical, instrumental and biochemical sign. iOAT does not respond to therapy and affected men often require assistance if they are to reproduce. This study is investigating a new therapy for iOAT.

Who can participate?
Infertile men, aged 20-50 years with iOAT.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given the drug Flortec-Bracco once a day for three months. Participants in group 2 are given a placebo (starch) tablet 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 are the possible benefits and risks of participating?
The only benefit for participating will be the fact that patients treated with the active drug might have their problem cured. No side effect s are expected.

Where is the study run from?
Gynepro Medical (Italy)

When is the study starting and how long is it expected to run for?
January 2015 to December 2016

Who is funding the study?
Gynepro Medical (Italy)

Who is the main contact?
Dr Carlo Maretti

Trial website

Contact information

Type

Public

Primary contact

Dr Carlo Maretti

ORCID ID

Contact details

via Somaglia 10
Piacenza
29121
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016/1

Study information

Scientific title

Oral administration of a placebo (starch) or of an active drug (L. paracasei B21060 + arabinogalattan and fruttoligosaccarides (Flortec-Bracco)) to two distinct populations of (oligo)±(atheno)±(terato) spermic infertile patients. Comparison of efficacy and of safety between placebo and active drug for the treatment of (Oligo)±(atheno)±(terato) spermia associated to idiopathic male infertility.

Acronym

EPA (Evidence for Pregnancy Achievement)

Study hypothesis

The aim of this study is to assess whether oral administration of probiotics and prebiotics (L. paracasei B21060 + arabinogalattan and fruttoligosaccarides (Flortec-Bracco)) improves sperm count and fertility of dyspermic infertile patients.

Ethics approval

Bioethics Committee, GynePro Medical, 29/06/2016, ref: CdB 0112016

Study design

Interventional double blind placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Idiopathic (Oligo)±(atheno)±(terato) spermia associated to male infertility.

Intervention

This study consists of two arms. Participants will be randomly allocated to one of these arms.

The patients of the first arm will be treated with active drug: L. paracasei B21060 + arabinogalattan and fruttoligosaccarides (Flortec-Bracco) one medicine sachet (containing L. paracasei B21060≥ 5 x 109 Colony Forming Units, Arabinogalattan 1.243 g, fructo-oligosaccarides 700 mg, L-glutammin 500 mg) once a day for six months.

The patients of the second arm will assume one 1 g starch tablet once a day for three months.

Three months after the suspension of the therapies the patients of both arms will be submitted to sperm analysis, hormonal assessment and bilateral scrotal echographic scan. Medical events occurred in this time will be recorded as well.




Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Sperm concentration, sperm motility and percentage of typical sperm forms, measured at baseline and at 3 months

Secondary outcome measures

1. The number of biochemical pregnancies (detected by measuring serum β-hCG on at least two occasions 14 days after the last expected menstruation)
2. The numbers of clinical pregnancies (defined as detectable heart activity)

The differences between active drug or placebo group were assessed using the Mann–Whitney U test.

Overall trial start date

02/01/2015

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infertile (oligo)±(atheno)±(terato) spermic infertile males aged 20-50
2. Normal sperm appearance, consistency, liquefaction, volume, and pH.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

This is a prospective blind placebo controlled trial. Active drug has no side effect thus a power analysis will be performed to estimate the number of observations we need to have a reliable chance of detecting the effect we are looking for. Since there are no formal standards for power (π), we have assessed the power of our tests using π = 0.90 as a standard for adequacy. This convention implies a ten-to-one trade off between β-risk and α-risk. Beta is the probability of a type-II error (not detecting a difference between the patients groups when one actually exists: false negative) this research used a 10% cut-off; α is the probability of a type-I error (finding a difference betwenn the patient groups when a difference does not exist: false positive), this research used a 1% cut-off (Mc Donald et al. 2009). The power calculations were performed with G*Power 3 statistical power analysis program (Faul et al. 2007). At worst 40 patients for each cluster will be studied. (Faul et al. 2007). References Faul, F, Erdfelder E, Lang, AG, & Buchner, A. (2007) G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Meth. 39, 175-191. McDonald JH (2009) Handbook of Biological Statistics (2nd Edition), Sparky House Publishing, Baltimore MD.

Participant exclusion criteria

1. Azoospermia
2. Seminal white blood cell concentration greater than 1 million/ml and/or a positive seminal cultural analysis or 3. Positive urethral swab chlamydia test
4. Drug, tobacco, or alcohol abuse
5. Ongoing medical treatment
6. Previous cancer radiotherapy or chemotherapy
7. Palpable varicocele
8. X-ray exposure in the previous 8 months
9.Y chromosome microdeletion
10. Karyotype alterations
11. Presence of female factors for infertility
12. Female partner age > 35 years

Recruitment start date

01/02/2015

Recruitment end date

01/12/2016

Locations

Countries of recruitment

Italy

Trial participating centre

Gynepro Medical
via Tanquillo Cremona 8
Bologna
40137
Italy

Sponsor information

Organisation

Gynepro Medical

Sponsor details

via Tranquillo Cremona 8
Bologna
40137
Italy

Sponsor type

Hospital/treatment centre

Website

http://www.gynepro.it/

Funders

Funder type

Industry

Funder name

Gynepro Medical

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

01/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes