Live microbial feed supplements for male infertility
| ISRCTN | ISRCTN66168088 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66168088 |
| Secondary identifying numbers | 2016/1 |
- Submission date
- 19/08/2016
- Registration date
- 08/09/2016
- Last edited
- 11/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Public
via Somaglia 10
Piacenza
29121
Italy
Study information
| Study design | Interventional double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| 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. |
| Study acronym | EPA (Evidence for Pregnancy Achievement) |
| Study objectives | 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(s) | Bioethics Committee, GynePro Medical, 29/06/2016, ref: CdB 0112016 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 02/01/2015 |
| Completion date | 01/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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. |
| Key inclusion criteria | 1. Infertile (oligo)±(atheno)±(terato) spermic infertile males aged 20-50 2. Normal sperm appearance, consistency, liquefaction, volume, and pH |
| Key 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 |
| Date of first enrolment | 01/02/2015 |
| Date of final enrolment | 01/12/2016 |
Locations
Countries of recruitment
- Italy
Study participating centre
Bologna
40137
Italy
Sponsor information
Hospital/treatment centre
via Tranquillo Cremona 8
Bologna
40137
Italy
| Website | http://www.gynepro.it/ |
|---|---|
"ROR" |
https://ror.org/03segdh23 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Giorgio Cavallini |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2017 | Yes | No |
Editorial Notes
11/07/2018: IPD sharing statement added.
10/07/2018: Publication reference added.
