The Benefits of Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) in Couples With Unexplained Infertility
NCT ID: NCT01729533
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-12-31
2013-02-28
Brief Summary
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The investigators hypothesized that couples with unexplained infertility could benefit from the injection of spermatozoa selected under high-magnification (x6600)
Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ICSI
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.
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.
IMSI
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing assisted reproduction as a result of unexplained infertility
* Women with regular menstrual cycles of 25-35 days
* Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels
* Women with body mass index (BMI) less than 30 kg/m2
* Women with both ovaries and intact uterus
Exclusion Criteria
* Women with polycystic ovaries
* Women with endometriosis
* Women with gynaecological/medical disorders
* Women or men with a positive result for sexually transmitted diseases
* Women who had received hormone therapy for at least 60 days preceding the study
36 Years
FEMALE
Yes
Sponsors
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Sapientiae Institute
OTHER
Responsible Party
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Locations
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Sapientiae Institute
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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IMSI_unexplained infertility
Identifier Type: -
Identifier Source: org_study_id