Clinical trial NCT02585297: The Presence of Microbes in the Sperm and Their Impact on Sperm Capacitation and IVF Treatment
Official title: The Presence of Microbes in the Sperm and Their Impact on Sperm Capacitation and IVF Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile coupls

Brief 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. Finding the incidence of vaginal bacteria and their relationship to bacteria of the sperm
5. 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.

Eligibility criteria: Inclusion Criteria:

* Male and female undergoing fertility treatments

Exclusion Criteria:

* Male and female not undergoing fertility treatments

Primary outcomes:
measure: The percent of successful IFV treatments
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Bacteriospermia and sperm quality in infertile male patient
citation: 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.
citation: Hou 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.
citation: Weng 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.