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

Nadezhda Women's Health Hospital

Status: Completed

Conditions: Infertility, Male

Treatments: Other: Conventional sperm selection; Other: Zona pellucida sperm selection; Other: Intracytoplasmic Sperm Injection (ICSI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05161247

59/03122021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 368 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis for primary or secondary infertility
• Healthy females
• Clinical diagnosis for unexplained infertility
• Females between 20 and 45 years old.
• Males between 20 and 50 years old.
• At least 3 retrieved oocytes per follicular puncture with at least 1 oocyte at germinal vesicle (GV) or metaphase I (MI) stage

Exclusion criteria

• Presence of low quality oocytes
• Females with endometrial or ovarian infertility factor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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368 participants in 2 patient groups

Zona pellucida sperm selection

Experimental group

Description:

Semen processing: liquefaction followed by centrifugation and swim-up. Zona pellucida sperm selection: Spermatozoa are selected according to their ability to adhere to zona pellucida proteins obtained from their partners native zona pellucida. Intracytoplasmic sperm injection (ICSI): Each oocyte is injected with a single morphologically normal spermatozoa. The injection procedure is carried out in a sterilized dish using holding pipette and injection needle.

Treatment:

Other: Intracytoplasmic Sperm Injection (ICSI)

Other: Zona pellucida sperm selection

Conventional sperm selection

Active Comparator group

Description:

Semen processing: liquefaction followed by centrifugation and swim-up. Samples are incubated until time of injection. Conventional sperm selection: Spermatozoa are selected according to their morphology. Intracytoplasmic sperm injection (ICSI): Each oocyte is injected with a single morphologically normal spermatozoa. The injection procedure is carried out in a sterilized dish using holding pipette and injection needle.

Treatment:

Other: Intracytoplasmic Sperm Injection (ICSI)

Other: Conventional sperm selection