Evaluation of Clinical Outcomes of Artificial Oocyte Activation in Intra Cytoplasmic Sperm Injection Candidates
Phase 2
- Conditions
- Male factor infertility.Male infertility
- Registration Number
- IRCT201510257223N7
- Lead Sponsor
- Royan Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
Inclusion Criteria: Infertile couples with male factor etiology showing 99-100 % abnormal sperm morphology
Exclusion Criteria
Females with higher than 45, with less than 6 matured oocytes, immature, deformed.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sperm concentration. Timepoint: In daye of ICSI procedure. Method of measurement: Light microscopy according to (WHO, 2010) criteria.;Sperm motility. Timepoint: In daye of ICSI procedure. Method of measurement: Light microscopy according to (WHO, 2010) criteria.;Sperm morphology. Timepoint: In daye of ICSI procedure. Method of measurement: Light microscopy according to (WHO, 2010) criteria.;Fertilization rate. Timepoint: 16 - 20 h after injection. Method of measurement: View of two pronuclei with invert microscope.;Quality of embryo. Timepoint: Three days after injection. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size.;Chemical pregnancy. Timepoint: 14 days after ET (Embryo Transfer). Method of measurement: Measurement of quantitative serum ß-hCG.;Clinical pregnancy. Timepoint: 5 - 6 weeks following ET. Method of measurement: Ultrasound detection of an intrauterine gestational sac with a positive fetal heartbeat.
- Secondary Outcome Measures
Name Time Method