Pregnancy
Conditions
Keywords
ICSI, IMSI, Pregnancy, Sperm morphology, Unexplained infertility
Brief 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)
Interventions
OTHERICSI
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.
OTHERIMSI
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
Sapientiae Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 36 Years
Healthy volunteers
Yes
Inclusion criteria
* Women of good physical and mental health * 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
* Men with abnormal semen parameters according to the 2010 WHO values * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | 1 month | Number of pregnancies divided by the number of cycles with embryo transfer |
Countries
Brazil
Outcome results
None listed