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

November 18, 2025 updated by: Sunrise Fertility Center

Evaluating the Use of Advanced Sperm Selection Methods on ICSI Procedure Outcomes by Physiological Intracytoplasmic Sperm Injection (PICSI) Verses ZyMot Device

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.
  • Inclusion criteria of male partner were; presence of ejaculate motile spermatozoa with total sperm number 1 million/ml at least and sperm motility 5% or more and all patient with high DNA fragmentation index above 35%.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: ICSI group
Sperm selection performed using traditional methods
Active Comparator: : 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.
Device: picsi dish
theses techniques to selection mature and lowest DNA fragmentation sperm for injection in oocyte
Other Names:
  • zymot device
Active Comparator: 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
Device: picsi dish
theses techniques to selection mature and lowest DNA fragmentation sperm for injection in oocyte
Other Names:
  • zymot device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome measure
Time Frame: 6-9 weeks after embryo transfer.

1• clinical pregnancy rate:- defined as the presence of a fetal heartbeat or gestational sac.

• Unit of Measure: Percentage (%)
6-9 weeks after embryo transfer.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
secondary outcome measure
Time Frame: 1-After 6 weeks of gestation.
1- Miscarriage rate: Defined as pregnancy loss following confirmation of clinical pregnancy. Unit of Measure: Percentage (%)
1-After 6 weeks of gestation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunrise Fertility Center

Investigators

  • Principal Investigator: Ayat samir kamel, Sunrise Fertility Center
  • Study Director: Rafaat Gabre, phd, faculity of science, cairo University
  • Study Director: Omaima Idris, phd, faculity of medicien, cairo university
  • Study Chair: Abeer mohsen, faculity of science, cairo University
  • Study Chair: Ahmed Said, Faculty of Science, Al-Azhar University, Assiut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2025

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PICSI-ZYMOT methods

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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