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

• Conditions: Infertility
• Interventions: Other: no intervention

• Registration Number: NCT02585297
• Lead Sponsor: Meir Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-22
• Last Update Submitted: 2015-10-22
• Study First Posted: 2015-10-23
• Last Update Posted: 2015-10-23
• Primary Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male and female undergoing fertility treatments

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Exclusion Criteria

• Male and female not undergoing fertility treatments

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control- vaginal discharge	no intervention	Vaginal discharge of partners of fertile men
Case-semen	no intervention	Semen of infertile men
Case- vaginal discharge	no intervention	Vaginal discharge of partners of infertile men
Control- semen	no intervention	Semen of fertile men

Primary Outcome Measures

Name	Time	Method
The percent of successful IFV treatments	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