Advanced Sperm Selection in ICSI: A Comparative Study of PICSI and ZyMot

NCT ID: NCT07240779

Last Updated: 2025-11-21

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2026-02-28

Brief Summary

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our study explores the effectiveness of two advanced sperm selection techniques-PICSI and the ZyMot microfluidic device-in improving outcomes of Intracytoplasmic Sperm Injection (ICSI). It aims to compare their impact on fertilization rates, embryo quality, and clinical pregnancy success, helping determine which method offers superior results in assisted reproductive technology.

Detailed Description

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Conditions

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Infertile Patient Undergoing ICSI Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICSI group

Sperm selection performed using traditional methods

Group Type NO_INTERVENTION

No interventions assigned to this group

: PICSI Group

* Sperm selection performed using the Physiological Intracytoplasmic Sperm Injection (PICSI) method.
* Hyaluronic acid-based selection to choose mature, DNA-intact sperm.
* Followed by standard ICSI procedure.

Group Type ACTIVE_COMPARATOR

picsi dish

Intervention Type DEVICE

theses techniques to selection mature and lowest DNA fragmentation sperm for injection in oocyte

ZyMot Group

* Sperm selection performed using the ZyMot microfluidic device.
* Mimics natural sperm migration to isolate motile, morphologically normal sperm.
* Followed by standard ICSI procedure

Group Type ACTIVE_COMPARATOR

picsi dish

Intervention Type DEVICE

theses techniques to selection mature and lowest DNA fragmentation sperm for injection in oocyte

Interventions

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picsi dish

theses techniques to selection mature and lowest DNA fragmentation sperm for injection in oocyte

Intervention Type DEVICE

Other Intervention Names

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zymot device

Eligibility Criteria

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Inclusion Criteria

* Age for women is between 20-39 years old.
* Body mass index (BMI) between 19 kg/m and 35 kg/m
* Normal Prolactin level.
* No other endocrinological abnormality including thyroid disorder or diabetes.
* With antimullerian hormone (AMH) at least 1.5 ng/ml, ), with normal progesterone level.
* Primary or secondary infertility at least of 2 years duration.
* No evidence of endometriosis.
* No other medical or surgical disease.
* The day of embryo freezing is the fifth day (day 5), and all patients who undergo the process of transferring frozen embryos.
* The endometrium thickness is between 8-14 mm on day of transfer.

Exclusion Criteria

* Women were older than 40 years of age or younger than 18 years old.
* Women laparoscopically diagnosed to have endometriosis within the last 1 year.
* Male infertility factor with immotile sperm.
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sunrise Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayat samir kamel

Role: PRINCIPAL_INVESTIGATOR

Sunrise Fertility Center

Rafaat Gabre, phd

Role: STUDY_DIRECTOR

faculity of science, Cairo university

Omaima Idris, phd

Role: STUDY_DIRECTOR

faculity of medicien, cairo university

Abeer mohsen

Role: STUDY_CHAIR

faculity of science, cairo University

Ahmed Said

Role: STUDY_CHAIR

Faculty of Science, Al-Azhar University, Assiut

Central Contacts

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Ayat samir kamel

Role: CONTACT

01002319165

Other Identifiers

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PICSI-ZYMOT methods

Identifier Type: -

Identifier Source: org_study_id

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