Comparison of fertilization percentage, embryo quality, implantation and pregnancy rate, between two sperm separation procedures in infertile men intra-cytoplasmic sperm injection candidate
Not Applicable
- Conditions
- Male factor infertility.Male infertility
- Registration Number
- IRCT201610317223N8
- Lead Sponsor
- Royan Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 113
Inclusion Criteria
Primary male factor infertility (according to the WHO-2010); with mean age of 20-45.
Exclusion criteria: Females factor infertility based on WHO criteria (2010); age higher than 35 years; less than 6 oocytes and poor quality oocyte
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fertilization rate. Timepoint: 16-18 h post insemination/injection. Method of measurement: View of 2 pronucleuse with invert microscope,the ratio of fertilized oocytes (2PN) by the total number of injected metaphase II oocytes, multiplied by 100.;Implantation rate. Timepoint: 4 weeks after transfer. Method of measurement: The number of observed gestational sacs per number of transferred.;Chemical pregnancy. Timepoint: 18 days post-ICSI. Method of measurement: Measurement of Beta HCG level in serum.;Clinical pregnancy. Timepoint: 5 weeks after embryo transfer. Method of measurement: ultrasonography findings showing at least one embryo with a fetal heartbeat.;Quality of embryo. Timepoint: On day 3 after oocyte retrieval. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size.
- Secondary Outcome Measures
Name Time Method Perinatal mortality ( fetal or neonatal death). Timepoint: At 20 completed weeks of gestational age and later, during childbirth, or up to 7 completed days after birth. Method of measurement: Through ultrasound.;Miscarriage (The spontaneous loss of a clinical pregnancy ). Timepoint: Before 20 completed weeks of gestational age (18 weeks after fertilization). Method of measurement: Through ultrasound.