An interventional study of MSOME in Pregnancy, sponsored by Sapientiae Institute. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2014-11-18.
Sponsored by Sapientiae Institute · Not applicable, Interventional, and Diagnostic
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.
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.
Sapientiae Institute is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The samples will be evaluated under high magnification
Other: MSOME
The 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.
Pregnancy rates
Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed.
Time frame: 1 month
Implantation rates
Number of gestational sacs divided by the number of transferred embryos.
Time frame: 1 month
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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