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

Sunrise Fertility Center

Status: Not yet enrolling

Conditions: Infertile Patient Undergoing ICSI Procedure

Treatments: Device: picsi dish

Study type: Interventional

Funder types: Other

Identifiers

NCT07240779

PICSI-ZYMOT methods

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

ICSI group

No Intervention group

Description:

Sperm selection performed using traditional methods

: PICSI Group

Active Comparator group

Description:

* 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.

Treatment:

Device: picsi dish

ZyMot Group

Active Comparator group

Description:

* Sperm selection performed using the ZyMot microfluidic device. * Mimics natural sperm migration to isolate motile, morphologically normal sperm. * Followed by standard ICSI procedure

Treatment:

Device: picsi dish