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

NCT01729533 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-11-18

No results posted yet for this study

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)

Conditions

  • Pregnancy

Interventions

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.

Sponsors & Collaborators

  • Sapientiae Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01729533 on ClinicalTrials.gov