NCT01729533

The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sapientiae Institute · Academic / Other
• Sex: Female
• Age: 36 Years
• Healthy volunteers: Accepted

Summary

The (motile sperm organelle morphology examination) MSOME allows the detection of sperm vacuoles that seems to be related to sperm DNA damage. The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)

Detailed description

When routine infertility workup yields normal results in both partners, the couple is defined as suffering from unexplained infertility. These couples present normal semen analysis. It has been reported that even infertile patients with normozoospermic parameters can have higher values of DNA damage than fertile controls. It has been proposed that the use of ''invisible damaged'' spermatozoa could result in fertilization failure, impaired normal embryo development, reduced implantation and pregnancy rates. The motile sperm organelle morphology examination (MSOME) allows the detection of sperm vacuoles that seems to be related to sperm DNA damage. The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)

Conditions

• Pregnancy

Interventions

Type	Name	Description
OTHER	ICSI	ICSI Sperm selection in the ICSI group is analyzed under a magnification of 400x using an inverted microscope. ICSI is performed in a micro-injection dish prepared with 4 µL droplets of buffered medium and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.
OTHER	IMSI	Sperm selection in the IMSI group is analyzed at high magnification using an inverted microscope equipped with high-power differential interference contrast optics. The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei (\[1\] smooth, \[2\] symmetric, and \[3\] oval configuration) and \[4\] normal nuclear chromatin content (if it contained no more than one vacuole, which occupies \<4% of the nuclear area) are selected for injection.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-11-20
• Last updated: 2014-11-18

Locations

1 site across 1 country: Brazil