An interventional study of ICSI and IMSI in Pregnancy, sponsored by Sapientiae Institute. Withdrawn at 1 site in Brazil. Open to female participants aged Up to 36 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-18.
Sponsored by Sapientiae Institute · Not applicable, Interventional, and Treatment
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)
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)
Sapientiae Institute is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
In this arm, patients will be provided with standard intracytoplasmic sperm injection (ICSI), in which sperm selection is performed under an overall magnification of x400.
Other: ICSI
In this arm, patients will be provided with a modified intracytoplasmic sperm injection (ICSI) procedure, the IMSI, in which sperm selection is performed under an overall magnification of x6600.
Other: IMSI
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.
Also known as: Intracytoplasmic sperm injection
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.
Also known as: Intracytoplasmic morphologically selected sperm injection
Pregnancy rate
Number of pregnancies divided by the number of cycles with embryo transfer
Time frame: 1 month
The record gives a start of Dec 2012, a primary completion of Feb 2013 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Sapientiae Institute