NCT05161247

Reproductive Outcome After Sperm Selection for Intracytoplasmic Sperm Injection (ICSI) Using Zona Pellucida Proteins

Assessment of the IVF Outcome Parameters After Sperm Selection by Adhesion to Zona Pellucida Proteins

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Nadezhda Women's Health Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Infertility, Male

Interventions

Type	Name	Description
OTHER	Zona pellucida sperm selection	Sperm selection for ICSI based on the spermatozoa ability to adhere to immobilized zona pellucida proteins.
OTHER	Conventional sperm selection	Sperm selection for ICSI based on the sperm morphology.
OTHER	Intracytoplasmic Sperm Injection (ICSI)	Normal ICSI procedure.

Timeline

• Start date: 2021-12-03
• Primary completion: 2024-03-03
• Completion: 2024-07-05
• First posted: 2021-12-17
• Last updated: 2025-05-21

Locations

1 site across 1 country: Bulgaria