InfertilityNCT02585297
The Presence of Microbes in the Sperm and Their Impact on Sperm Capacitation and IVF Treatment
An observational study of Infertility, run by Meir Medical Center.
Trial summary
Study Goals: 1. Finding the prevalence of bacteria of the sperm in an innovative and more accurate methode 2. Understanding the effect of microbes on the process of capacitation 3. The impact of microbes in the sperm on IVF success rate 4. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Infertile coupls
Who may be able to join
- Male and female undergoing fertility treatments
Who cannot join
- Male and female not undergoing fertility treatments
About this study
Study Goals:
- Finding the prevalence of bacteria of the sperm in an innovative and more accurate methode
- Understanding the effect of microbes on the process of capacitation
- The impact of microbes in the sperm on IVF success rate
- Finding the incidence of vaginal bacteria and their relationship to bacteria of the sperm
- The impact of vaginal flora on IVF success rate
Read the detailed description
Prospective non interventional study in the Department of Life Sciences, Bar-Ilan University and IVF Unit at Meir Hospital.
The control group consisting of 50 semen samples from men with no sperm problems and 50 vaginal samples from their partners.
The study group consisting of 50 semen samples from men with male fertility problems and 50 vaginal samples from their partners.
The semen taken from the remains after fertilization of the IVF laboratory. (Liquid otherwise routinely thrown).
Vaginal samples taken from women undergoing IVF treatment under anesthesia after informed consent.
Enrollment also collect the following data: age, race, chronic illnesses, past surgeries and former fertility treatments. Data will be collected through anamnesis of the patient or the medical file after consent.
- Conditions
- Infertility
- Being tested
- no intervention
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Control- semen | Semen of fertile men Receives: Other: no intervention | |
| Control- vaginal discharge | Vaginal discharge of partners of fertile men Receives: Other: no intervention | |
| Case-semen | Semen of infertile men Receives: Other: no intervention | |
| Case- vaginal discharge | Vaginal discharge of partners of infertile men Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of successful IFV treatments
Using 16-S Ribosomal RNA analysis to quantify and compare (type and percentages) of bacterial components in sperm samples from fertile and infertile men and their impact on IVF treatments success rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585297
- Sponsor's protocol ID
- Meir hospital
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trussell JC. Optimal diagnosis and medical treatment of male infertility. Semin Reprod Med. 2013 Jul;31(4):235-6. doi: 10.1055/s-0033-1345269. Epub 2013 Jun 17. No abstract available.
PubMed 23775377Rittenberg V, El-Toukhy T. Medical treatment of male infertility. Hum Fertil (Camb). 2010 Dec;13(4):208-16. doi: 10.3109/14647273.2010.534833.
PubMed 21117930Diemer T, Huwe P, Ludwig M, Hauck EW, Weidner W. Urogenital infection and sperm motility. Andrologia. 2003 Oct;35(5):283-7.
PubMed 14535856Goldenberger D, Kunzli A, Vogt P, Zbinden R, Altwegg M. Molecular diagnosis of bacterial endocarditis by broad-range PCR amplification and direct sequencing. J Clin Microbiol. 1997 Nov;35(11):2733-9. doi: 10.1128/jcm.35.11.2733-2739.1997.
PubMed 9350723Akutsu T, Motani H, Watanabe K, Iwase H, Sakurada K. Detection of bacterial 16S ribosomal RNA genes for forensic identification of vaginal fluid. Leg Med (Tokyo). 2012 May;14(3):160-2. doi: 10.1016/j.legalmed.2012.01.005. Epub 2012 Feb 7.
PubMed 22316585Domes T, Lo KC, Grober ED, Mullen JB, Mazzulli T, Jarvi K. The incidence and effect of bacteriospermia and elevated seminal leukocytes on semen parameters. Fertil Steril. 2012 May;97(5):1050-5. doi: 10.1016/j.fertnstert.2012.01.124. Epub 2012 Feb 16.
PubMed 22341372Bacteriospermia and sperm quality in infertile male patient
De Francesco MA, Negrini R, Ravizzola G, Galli P, Manca N. Bacterial species present in the lower male genital tract: a five-year retrospective study. Eur J Contracept Reprod Health Care. 2011 Feb;16(1):47-53. doi: 10.3109/13625187.2010.533219. Epub 2010 Nov 23.
PubMed 21091298Hou D, Zhou X, Zhong X, Settles ML, Herring J, Wang L, Abdo Z, Forney LJ, Xu C. Microbiota of the seminal fluid from healthy and infertile men. Fertil Steril. 2013 Nov;100(5):1261-9. doi: 10.1016/j.fertnstert.2013.07.1991. Epub 2013 Aug 29.
PubMed 23993888Weng SL, Chiu CM, Lin FM, Huang WC, Liang C, Yang T, Yang TL, Liu CY, Wu WY, Chang YA, Chang TH, Huang HD. Bacterial communities in semen from men of infertile couples: metagenomic sequencing reveals relationships of seminal microbiota to semen quality. PLoS One. 2014 Oct 23;9(10):e110152. doi: 10.1371/journal.pone.0110152. eCollection 2014.
PubMed 25340531
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Presence of Microbes in the Sperm and Their Impact on Sperm Capacitation and IVF Treatment
- ClinicalTrials.gov ID
- NCT02585297
- Acronym / sponsor ID
- Meir hospital
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Goals:
- Finding the prevalence of bacteria of the sperm in an innovative and more accurate methode
- Understanding the effect of microbes on the process of capacitation
- The impact of microbes in the sperm on IVF success rate
- Finding the incidence of vaginal bacteria and their relationship to bacteria of the sperm
- The impact of vaginal flora on IVF success rate
Detailed description
Prospective non interventional study in the Department of Life Sciences, Bar-Ilan University and IVF Unit at Meir Hospital.
The control group consisting of 50 semen samples from men with no sperm problems and 50 vaginal samples from their partners.
The study group consisting of 50 semen samples from men with male fertility problems and 50 vaginal samples from their partners.
The semen taken from the remains after fertilization of the IVF laboratory. (Liquid otherwise routinely thrown).
Vaginal samples taken from women undergoing IVF treatment under anesthesia after informed consent.
Enrollment also collect the following data: age, race, chronic illnesses, past surgeries and former fertility treatments. Data will be collected through anamnesis of the patient or the medical file after consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control- semen | – | Other: no interventionSemen of fertile men |
| Control- vaginal discharge | – | Other: no interventionVaginal discharge of partners of fertile men |
| Case-semen | – | Other: no interventionSemen of infertile men |
| Case- vaginal discharge | – | Other: no interventionVaginal discharge of partners of infertile men |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Infertile coupls
Key inclusion criteria (1 listed)
- Male and female undergoing fertility treatments
Key exclusion criteria (1 listed)
- Male and female not undergoing fertility treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | Case- vaginal discharge, Case-semen, Control- semen, Control- vaginal discharge |
Primary outcome
The percent of successful IFV treatments
Time frame: 24 months
Using 16-S Ribosomal RNA analysis to quantify and compare (type and percentages) of bacterial components in sperm samples from fertile and infertile men and their impact on IVF treatments success rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- Background: PubMed 23775377Trussell JC. Optimal diagnosis and medical treatment of male infertility. Semin Reprod Med. 2013 Jul;31(4):235-6. doi: 10.1055/s-0033-1345269. Epub 2013 Jun 17. No abstract available.
- Background: PubMed 21117930Rittenberg V, El-Toukhy T. Medical treatment of male infertility. Hum Fertil (Camb). 2010 Dec;13(4):208-16. doi: 10.3109/14647273.2010.534833.
- Background: PubMed 14535856Diemer T, Huwe P, Ludwig M, Hauck EW, Weidner W. Urogenital infection and sperm motility. Andrologia. 2003 Oct;35(5):283-7.
- Background: PubMed 9350723Goldenberger D, Kunzli A, Vogt P, Zbinden R, Altwegg M. Molecular diagnosis of bacterial endocarditis by broad-range PCR amplification and direct sequencing. J Clin Microbiol. 1997 Nov;35(11):2733-9. doi: 10.1128/jcm.35.11.2733-2739.1997.
- Background: PubMed 22316585Akutsu T, Motani H, Watanabe K, Iwase H, Sakurada K. Detection of bacterial 16S ribosomal RNA genes for forensic identification of vaginal fluid. Leg Med (Tokyo). 2012 May;14(3):160-2. doi: 10.1016/j.legalmed.2012.01.005. Epub 2012 Feb 7.
- Background: PubMed 22341372Domes T, Lo KC, Grober ED, Mullen JB, Mazzulli T, Jarvi K. The incidence and effect of bacteriospermia and elevated seminal leukocytes on semen parameters. Fertil Steril. 2012 May;97(5):1050-5. doi: 10.1016/j.fertnstert.2012.01.124. Epub 2012 Feb 16.
- BackgroundBacteriospermia and sperm quality in infertile male patient
- Background: PubMed 21091298De Francesco MA, Negrini R, Ravizzola G, Galli P, Manca N. Bacterial species present in the lower male genital tract: a five-year retrospective study. Eur J Contracept Reprod Health Care. 2011 Feb;16(1):47-53. doi: 10.3109/13625187.2010.533219. Epub 2010 Nov 23.
- Background: PubMed 23993888Hou D, Zhou X, Zhong X, Settles ML, Herring J, Wang L, Abdo Z, Forney LJ, Xu C. Microbiota of the seminal fluid from healthy and infertile men. Fertil Steril. 2013 Nov;100(5):1261-9. doi: 10.1016/j.fertnstert.2013.07.1991. Epub 2013 Aug 29.
- Background: PubMed 25340531Weng SL, Chiu CM, Lin FM, Huang WC, Liang C, Yang T, Yang TL, Liu CY, Wu WY, Chang YA, Chang TH, Huang HD. Bacterial communities in semen from men of infertile couples: metagenomic sequencing reveals relationships of seminal microbiota to semen quality. PLoS One. 2014 Oct 23;9(10):e110152. doi: 10.1371/journal.pone.0110152. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent of successful IFV treatments (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585297, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.