Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07240779
Enrollment
300
Registered
2025-11-21
Start date
2025-11-15
Completion date
2026-02-28
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertile Patient Undergoing ICSI Procedure

Keywords

ICSI, PICSI, ZYMOT

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.

Interventions

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

Sponsors

Sunrise Fertility Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 39 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary outcome measure6-9 weeks after embryo transfer.1• clinical pregnancy rate:- defined as the presence of a fetal heartbeat or gestational sac. • Unit of Measure: Percentage (%)

Secondary

MeasureTime frameDescription
secondary outcome measure1-After 6 weeks of gestation.1- Miscarriage rate: Defined as pregnancy loss following confirmation of clinical pregnancy. Unit of Measure: Percentage (%)

Contacts

Primary ContactAyat samir kamel
ayatsamer@yahoo.com01002319165

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026