Reproductive Outcome After Sperm Selection for Intracytoplasmic Sperm Injection (ICSI) Using Zona Pellucida Proteins
NCT ID: NCT05161247
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
368 participants
INTERVENTIONAL
2021-12-03
2024-07-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Zona pellucida sperm selection
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.
Zona pellucida sperm selection
Sperm selection for ICSI based on the spermatozoa ability to adhere to immobilized zona pellucida proteins.
Intracytoplasmic Sperm Injection (ICSI)
Normal ICSI procedure.
Conventional sperm selection
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.
Conventional sperm selection
Sperm selection for ICSI based on the sperm morphology.
Intracytoplasmic Sperm Injection (ICSI)
Normal ICSI procedure.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Females with endometrial or ovarian infertility factor
20 Years
50 Years
ALL
No
Sponsors
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Nadezhda Women's Health Hospital
OTHER
Responsible Party
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Locations
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Nadezhda Women's Health Hospital
Sofia, Sofia, Bulgaria
Countries
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Other Identifiers
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59/03122021
Identifier Type: -
Identifier Source: org_study_id
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