Infertile Patient Undergoing ICSI ProcedureNCT07240779
Advanced Sperm Selection in ICSI: A Comparative Study of PICSI and ZyMot
A study testing picsi dish in people with Infertile Patient Undergoing ICSI Procedure, run by Sunrise Fertility Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertile Patient Undergoing ICSI Procedure
- What is being tested?
- picsi dish
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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%.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Use of Advanced Sperm Selection Methods on ICSI Procedure Outcomes by Physiological Intracytoplasmic Sperm Injection (PICSI) Verses ZyMot Device
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.
- Being tested
- picsi dish
- Keywords
- ICSI, PICSI, ZYMOT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
picsi dishDevice
Also called zymot device
theses techniques to selection mature and lowest DNA fragmentation sperm for injection in oocyte
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: picsi dish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
1• clinical pregnancy rate:- defined as the presence of a fetal heartbeat or gestational sac.
- Unit of Measure: Percentage (%)
Measured: 6-9 weeks after embryo transfer.
Secondary outcomes (1)
secondary outcome measure
1- Miscarriage rate: Defined as pregnancy loss following confirmation of clinical pregnancy. Unit of Measure: Percentage (%)
Measured: 1-After 6 weeks of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile Patient Undergoing ICSI ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunrise Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayat samir kamel, Principal investigator, Sunrise Fertility CenterRafaat Gabre, phd, Study director, faculity of science, Cairo universityOmaima Idris, phd, Study director, faculity of medicien, cairo universityAbeer mohsen, Study chair, faculity of science, cairo UniversityAhmed Said, Study chair, Faculty of Science, Al-Azhar University, Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240779
- Sponsor's protocol ID
- PICSI-ZYMOT methods
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Advanced Sperm Selection Methods on ICSI Procedure Outcomes by Physiological Intracytoplasmic Sperm Injection (PICSI) Verses ZyMot Device
- ClinicalTrials.gov ID
- NCT07240779
- Acronym / sponsor ID
- PICSI-ZYMOT methods
- Keywords
- ICSI, PICSI, ZYMOT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sunrise Fertility CenterUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICSI group | No intervention | –Sperm selection performed using traditional methods |
| : PICSI Group | Active comparator | Device: picsi dish* 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. |
| ZyMot Group | Active comparator | Device: picsi dish* Sperm selection performed using the ZyMot microfluidic device. * Mimics natural sperm migration to isolate motile, morphologically normal sperm. * Followed by standard ICSI procedure |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| picsi dishAlso: zymot devicetheses techniques to selection mature and lowest DNA fragmentation sperm for injection in oocyte | Device | : PICSI Group, ZyMot Group |
Primary outcome
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 (%)
1 secondary outcome
secondary outcome measure
Time frame: 1-After 6 weeks of gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayat samir kamel principal investigator
Sunrise Fertility Center
Rafaat Gabre, phd study director
faculity of science, Cairo university
Omaima Idris, phd study director
faculity of medicien, cairo university
Questions about this trial
What is this clinical trial studying?
A study testing picsi dish in people with Infertile Patient Undergoing ICSI Procedure, run by Sunrise Fertility Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayat samir kamel (01002319165, ayatsamer@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure (time frame: 6-9 weeks after embryo transfer.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.