Comparison of clinical outcomes between two sperm separation procedures: Felix vs. DGC
Not Applicable
Recruiting
- Conditions
- Sperm selection procedure.Male infertility
- Registration Number
- IRCT20110804007223N11
- Lead Sponsor
- Royan Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Couples candidate for ICSI
The number of follicles: at least 10 MII oocytes.
Infertile couples with male factor infertility (sperm parameters lower than defined threshold by WHO 2021)
Female age = 38 years
Men with at least 2ml semen
Embryo transfer only at blastocyst stage
One blastocyst for transfer
Normal female (female will be considered as normal if they have a regular cycle with patent tube and absence of endometriosis )
Men with a total sperm cell count higher than 5 million per ejaculate
Exclusion Criteria
Men with testicular sperm extraction or epididymal sperm aspiration
Men with cryo-preserved semen samples
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blastocysts rate and quality. Timepoint: Day 5 or 6 after ICSI. Method of measurement: Microscope.
- Secondary Outcome Measures
Name Time Method Fertilization. Timepoint: 16-18 hours after ICSI. Method of measurement: The number of 2PNs divided by the number of MII oocytes injected by ICSI multiplied by 100.;Embryo quality. Timepoint: 2 or 3 day after ICSI. Method of measurement: According to DK Gardner criteria (2016).;Biochemical pregnancy. Timepoint: Post implantation. Method of measurement: Beta hCG level.;Clinical pregnancy. Timepoint: Fifth or sixth week of pregnancy. Method of measurement: The observation of a fetal sacs and also fetal heartbeat by sonography.;Implantation. Timepoint: One to two weeks after blastocyst transfer. Method of measurement: Sonography.;Livebirth. Timepoint: At the time of delivery. Method of measurement: By phone call.