The aim of this study is to analyze the effect of a sperm selection method by adhesion to partners' zona pellucida proteins on the assisted reproduction treatment (ART) outcome parameters.
The success rate after treatment by in-vitro fertilisation (IVF) depends on the sperm selection process. Classical sperm selection techniques are based on the spermatozoa morphology and motility, therefore are not able to measure the sperm ability to recognise the oocyte. Furthermore it is known that semen samples showing higher adherence rate to zona pellucida have higher fertilisation potential than spermatozoa that fail to bind to zona proteins. There have been numerous reports on applying partner' native zona pellucida in sperm selection prior ICSI. However, these studies imply the whole native zona pellucida, while this study will focus on the application of acid-solubilized zonae pellucidae. Here in this study, the aim is to assess the fertilisation rate, the number and quality of the formed embryos, implantation and ongoing pregnancy success after sperm selection for ICSI by their ability to adhere to immobilized zona pellucida proteins.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
368
Sperm selection for ICSI based on the spermatozoa ability to adhere to immobilized zona pellucida proteins.
Sperm selection for ICSI based on the sperm morphology.
Normal ICSI procedure.
Nadezhda Women's Health Hospital
Sofia, Sofia, Bulgaria
Fertilisation rate
Defined as number of fertilized oocytes (presence of 2 pronuclei) per total number of injected oocytes.
Time frame: 24 hours after ICSI
Embryo quality
Morphological evaluation of the cultured embryos will be conducted 120 or 144 hr following sperm injection. Blastocysts scoring will be performed on day 5 or 6 depending on the blastocoel cavity expansion and on the inner cell mass and trophectoderm cells integrity.
Time frame: 2 to 6 days after ICSI
Implantation rate
Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood per transfer.
Time frame: 14 days after embryo transfer
Clinical pregnancy rate
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 per number of embryo transferred.
Time frame: 6 weeks after embryo transfer
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