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Not yet recruiting NCT07240779

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

No phase Interventional Infertile Patient Undergoing ICSI Procedure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: picsi dish.
Who it may be relevant to
Registry conditions: Infertile Patient Undergoing ICSI Procedure. Basic parameters: 20 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device picsi dish
    theses techniques to selection mature and lowest DNA fragmentation sperm for injection in oocyte

Primary outcome measures

  • Primary outcome measure [Time frame: 6-9 weeks after embryo transfer.]
Secondary outcome measures (1)
  • secondary outcome measure [Time frame: 1-After 6 weeks of gestation.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07240779 · PICSI-ZYMOT methods

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗