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

Infertility, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05161247
• Other study ID #: 59/03122021
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 3, 2021
• Est. completion date: December 3, 2024

Study information

• Verified date: November 2023
• Source: Nadezhda Women's Health Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 3, 2024
• Est. primary completion date: March 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Other:
• Zona pellucida sperm selection
Sperm selection for ICSI based on the spermatozoa ability to adhere to immobilized zona pellucida proteins.
• Conventional sperm selection
Sperm selection for ICSI based on the sperm morphology.
• Intracytoplasmic Sperm Injection (ICSI)
Normal ICSI procedure.

Locations

Country	Name	City	State
Bulgaria	Nadezhda Women's Health Hospital	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Nadezhda Women's Health Hospital

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilisation rate	Defined as number of fertilized oocytes (presence of 2 pronuclei) per total number of injected oocytes.	24 hours after ICSI
Primary	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.	2 to 6 days after ICSI
Primary	Implantation rate	Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood per transfer.	14 days after embryo transfer
Primary	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.	6 weeks after embryo transfer