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

NCT07240779 | Not Yet Recruiting

• 1 other identifier: PICSI-ZYMOT methods
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infertile Patient Undergoing ICSI Procedure

Keywords

ICSI; PICSI; ZYMOT

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure

  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 Outcomes (1)

• secondary outcome measure

  1-After 6 weeks of gestation.

Study Arms (3)

ICSI group

NO INTERVENTION

Sperm selection performed using traditional methods

: PICSI Group

ACTIVE COMPARATOR

* 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

ZyMot Group

ACTIVE COMPARATOR

* 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

Interventions

picsi dish DEVICE

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

Also known as: zymot device

: PICSI Group; ZyMot Group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunrise Fertility Center: lead

Study Officials

• Ayat samir kamel

  Sunrise Fertility Center

  PRINCIPAL INVESTIGATOR

• Rafaat Gabre, phd

  faculity of science, Cairo university

  STUDY DIRECTOR

• Omaima Idris, phd

  faculity of medicien, cairo university

  STUDY DIRECTOR

• Abeer mohsen

  faculity of science, cairo University

  STUDY CHAIR

• Ahmed Said

  Faculty of Science, Al-Azhar University, Assiut

  STUDY CHAIR

Central Study Contacts

Ayat samir kamel

CONTACT

01002319165; ayatsamer@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 21, 2025
• Study Start: November 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: February 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11