NCT05724979

Brief Summary

In vivo, the zona pellucida (ZP) of the oocyte can bind to normally functional sperm. The ZP-sperm interaction is one of the final steps of natural selection during their journey in the female reproductive tract. In the current study, we evaluated the ability of the ZP of immature oocytes to harvest the fittest sperm. We compared the embryological outcomes of intracytoplasmic sperm injection (ICSI) using conventionally selected sperm (control group) and ZP-bound sperm (intervention group). Our results showed no statistically significant superiority for the ZP binding technique over the conventional sperm selection with respect to the rates of fertilization and cleavage. However; the rates of blastocyst formation and high-quality blastocysts were significantly improved in the intervention group compare to the control group. These findings imply that the proposed technique can serve as a cost-effective and natural sperm selection method that has the potential to enhance the embryological and clinical outcomes of intracytoplasmic sperm injection (ICSI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 5, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

December 11, 2022

Last Update Submit

February 2, 2023

Conditions

Intracytoplasmic Sperm InjectionInfertility, Male

Keywords

Intracytoplasmic sperm injection (ICSI)zona pellucida (ZP)natural sperm selectionSperm-oocyte interactionZP-bound sperm

Outcome Measures

Primary Outcomes (5)

  • fertilization rate

    percentage of transformation of micro injected oocytes into two pronuclei

    17-18 hours post ICSI

  • cleavage rate

    percentage of cleavage of fertilized oocytes into 2-4 cell embryos

    44 ± 1 h post ICSI

  • high-quality cleaved embryos rate

    percentage of total number of high-quality day-3 embryos by total number of cleaved embryos

    68 ± 1 h post ICSI

  • blastocyst formation rate

    percentage of total number of embryos transformed into blastocysts by total number of cleaved embryos

    107.9-112.9 hours after ICSI

  • high-quality blastocyst rate

    percentage of total number of high-quality expanded blastocysts on day 5 and/or 6 by total number of blastocysts

    107.9-112.9 hours after ICSI

Study Arms (2)

control

NO INTERVENTION

Oocytes of the control group were injected with conventionally selected spermatozoa based on sperm morphology and motility after being processed density gradient centrifugation

treatment

EXPERIMENTAL

ZP-bound sperm were selected from the surface of the immature oocytes through the use of a microneedle (Sunlight Medical, Jacksonville, FL, USA) and transferred in a 10 % polyvinylpyrrolidone (PVP) solution (SAGE, USA), immobilized, and then used to inject sibling MII oocytes

Other: ZP-binding

Interventions

ZP-bindingOTHER

The ZP is selective with regard to binding and can bind to normally functioning sperm, especially those with a normal acrosomal region

treatment

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Couples must be diagnosed with infertility and undergoing ICSI cycle.
  • The age range for all female subjects must be between 21 and 38 years old, and their male partners must be older than 24 years old and above 50 years old.
  • Patients must produce at least two mature oocytes (one to be used for control and one for treatment) and one immature oocyte (to be used for selecting sperm).
  • Males must show at least 10% total sperm motility

You may not qualify if:

  • Cases where the female was younger than 21 years or older than 38 years old.
  • Patients that had less than two mature oocytes
  • Patients with no immature oocytes
  • Patients with low oocyte quality.
  • Cases with less than 10% motility or those with no motility such as PESA, TESA, and TESE cases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, 11651, Egypt

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Nehal A Abu Elnaga, PhD

    Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Embryologist

Study Record Dates

First Submitted

December 11, 2022

First Posted

February 13, 2023

Study Start

March 5, 2021

Primary Completion

September 10, 2022

Study Completion

October 15, 2022

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)