The Presence of Microbes in the Sperm and Their Impact on Sperm Capacitation and IVF Treatment

NCT02585297 | Unknown DMC

• 1 other identifier: Meir hospital
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Goals:

1. 1.Finding the prevalence of bacteria of the sperm in an innovative and more accurate methode
2. 2.Understanding the effect of microbes on the process of capacitation
3. 3.The impact of microbes in the sperm on IVF success rate
4. 4.Finding the incidence of vaginal bacteria and their relationship to bacteria of the sperm
5. 5.The impact of vaginal flora on IVF success rate

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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

  24 months

Study Arms (4)

Control- semen

Semen of fertile men

Other: no intervention

Control- vaginal discharge

Vaginal discharge of partners of fertile men

Other: no intervention

Case-semen

Semen of infertile men

Other: no intervention

Case- vaginal discharge

Vaginal discharge of partners of infertile men

Other: no intervention

Interventions

no intervention OTHER

Case- vaginal discharge; Case-semen; Control- semen; Control- vaginal discharge

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infertile coupls

You may qualify if:

• Male and female undergoing fertility treatments

You may not qualify if:

• Male and female not undergoing fertility treatments

Sponsors & Collaborators

• Meir Medical Center: lead

Related Publications (10)

• 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.

  PMID: 23775377 BACKGROUND

• Rittenberg V, El-Toukhy T. Medical treatment of male infertility. Hum Fertil (Camb). 2010 Dec;13(4):208-16. doi: 10.3109/14647273.2010.534833.

  PMID: 21117930 BACKGROUND

• Diemer T, Huwe P, Ludwig M, Hauck EW, Weidner W. Urogenital infection and sperm motility. Andrologia. 2003 Oct;35(5):283-7.

  PMID: 14535856 BACKGROUND

• Goldenberger 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.

  PMID: 9350723 BACKGROUND

• Akutsu 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.

  PMID: 22316585 BACKGROUND

• Domes 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.

  PMID: 22341372 BACKGROUND

• Bacteriospermia and sperm quality in infertile male patient

  BACKGROUND

• 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.

  PMID: 21091298 BACKGROUND

• 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.

  PMID: 23993888 BACKGROUND

• 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.

  PMID: 25340531 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Semen and vaginal discharge

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 23, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Last Updated: October 23, 2015

Record last verified: 2015-10