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CompletedNCT01731639

Motile Sperm Organelle Morphology Examination (MSOME) Influence on Intracytoplasmic Sperm Injection (ICSI) Outcomes in Infertile Couples

The Influence of Motile Sperm Organelle Morphology Examination on ICSI Outcomes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
Sapientiae Institute · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing intracytoplasmic sperm injection (ICSI) outcomes.

Detailed description

Sperm morphology has been described as one of the major determinants of male in vitro fertility. However, the standard morphology evaluation on random stained cells from the ejaculate is of limited value during ICSI. Current research is directed towards the dysmorphisms of the sperm head.A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing ICSI outcomes. The goals for this study are to identify whether there is a connection between morphologic sperm normalcy under high magnification and (i) semen analysis according to the new World Health Organization (WHO) reference values and (ii) ICSI outcomes.

Conditions

Interventions

TypeNameDescription
OTHERMSOMEThe semen samples will be evaluated according to the 2010 WHO reference values. After ICSI 200 spermatozoa of each sample will be analyzed under high magnification (MSOME - x6600) and graded into four groups according to the presence or size of the vacuoles. Grade I: normal form and no vacuoles; grade II: normal form and ≤ 2 small vacuoles; grade III: normal form \> 2 small vacuoles or at least one large vacuole and grade IV: large vacuole and abnormal head shapes or other abnormalities.

Timeline

Start date
2013-01-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2012-11-22
Last updated
2014-11-18

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01731639. Inclusion in this directory is not an endorsement.

Motile Sperm Organelle Morphology Examination (MSOME) Influence on Intracytoplasmic Sperm Injection (ICSI) Outcomes in I (NCT01731639) · Clinical Trials Directory