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NCT Number: NCT07240779

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

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.

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Key information

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

picsi dish

Device

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

Other names: zymot device

Primary outcomes

  1. 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 (%)

Secondary outcomes

  1. 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 (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Ayat samir kamel

CONTACT

[email protected]

01002319165

Sponsors and collaborators

Lead sponsor

Sunrise Fertility Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.