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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05161247
Other study ID # 59/03122021
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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