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NCT Number: NCT05161247

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

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.

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Key information

Conditions

Infertility, Male Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nadezhda Women's Health Hospital

Sofia, 1373, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zona pellucida sperm selection

Other

Sperm selection for ICSI based on the spermatozoa ability to adhere to immobilized zona pellucida proteins.

Conventional sperm selection

Other

Sperm selection for ICSI based on the sperm morphology.

Intracytoplasmic Sperm Injection (ICSI)

Other

Normal ICSI procedure.

Primary outcomes

  1. Fertilisation rate

    Time frame: 24 hours after ICSI

    Defined as number of fertilized oocytes (presence of 2 pronuclei) per total number of injected oocytes.

  2. Embryo quality

    Time frame: 2 to 6 days after ICSI

    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.

  3. Implantation rate

    Time frame: 14 days after embryo transfer

    Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood per transfer.

  4. Clinical pregnancy rate

    Time frame: 6 weeks after embryo transfer

    Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 per number of embryo transferred.

Sponsors and collaborators

Lead sponsor

Nadezhda Women's Health Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2021
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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