NCT05161247

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2024

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

December 6, 2021

Last Update Submit

May 20, 2025

Conditions

Infertility, Male

Keywords

zona pellucidasperm selectionICSIART outcomes

Outcome Measures

Primary Outcomes (4)

  • Fertilisation rate

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

    24 hours after ICSI

  • 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

  • Implantation rate

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

    14 days after embryo transfer

  • 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

Study Arms (2)

Zona pellucida sperm selection

EXPERIMENTAL

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.

Other: Zona pellucida sperm selectionOther: Intracytoplasmic Sperm Injection (ICSI)

Conventional sperm selection

ACTIVE COMPARATOR

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.

Other: Conventional sperm selectionOther: Intracytoplasmic Sperm Injection (ICSI)

Interventions

Zona pellucida sperm selectionOTHER

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

Zona pellucida sperm selection
Conventional sperm selectionOTHER

Sperm selection for ICSI based on the sperm morphology.

Conventional sperm selection
Intracytoplasmic Sperm Injection (ICSI)OTHER

Normal ICSI procedure.

Conventional sperm selectionZona pellucida sperm selection

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nadezhda Women's Health Hospital

Sofia, Sofia, 1373, Bulgaria

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After couples are recruited for the study they will be randomly allocated to zona selection group (study group) and normal ICSI (control group). For the study group zonae pellucidae from germinal vesicle (GV) or metaphase I (MI) stage oocytes from the female partners will be collected and acid-solubilised to obtain zona proteins. The acid-solubilised zonae will be coated on petri dishes. On the day of their follicular punction the spermatozoa for ICSI in the study group will be selected according to their ability to adhere to the coated zona pellucida proteins from their partner. On the day of their follicular punction the spermatozoa for ICSI in the control group will be selected with no intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 17, 2021

Study Start

December 3, 2021

Primary Completion

March 3, 2024

Study Completion

July 5, 2024

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)