Sperm DNA FragmentationNCT05494216
Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates
A study testing PICSI and MACS in people with Sperm DNA Fragmentation and Infertility, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
Comparing different advanced sperm selection techniques like Physiological ICSI (PICSI) and magnetic activated cell sorting (MACS) in terms of the PGT-A outcomes of each arm blastocysts Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Sperm DNA Fragmentation, Infertility
- What is being tested?
- PICSI and MACS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Case must have PGT-A for all of her blastocysts
- Males diagnosed with abnormal sperm DNA fragmentation index (> 20%).
- Normo responder (> 5 mature oocytes)
- Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of ICSI
Who cannot join
- Leukocytospermia
- Presence of varicocele.
- Known genetic abnormality
- Use of sperm or oocyte donors
- Use of gestational carrier
- Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
- Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Comparing different advanced sperm selection techniques like Physiological ICSI (PICSI) and magnetic activated cell sorting (MACS) in terms of the PGT-A outcomes of each arm blastocysts
Read the detailed description
Advanced sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with lower Sperm DNA fragmentation. Previous studies compared the pre-implantation embryo development parameters of those techniques, but none looked at comparing the PGT-A results or euploidy rates of the blastocysts derived from each sperm selection.
PGT-A cases will be randomized on the day of ICSI to the 2 assigned sperm selection techniques.
- Conditions
- Sperm DNA Fragmentation, Infertility
- Being tested
- PICSI, MACS
- Keywords
- Sperm selection, PICSI, MACS, Sperm DNA fragmentation, PGT-A, Euploidy rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICSIOther
Sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
MACSOther
Sperm selection using MACS for selecting sperm with lower DNA fragmentation index
| Study group | Role | What they receive |
|---|---|---|
| PICSI | Active comparator | Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Individual bound sperm selection is done followed y ICSI Receives: Other: PICSI |
| MACS | Active comparator | Semen processing is done by double layer density gradient method. The resulted pellet is labeled with annexin V microbeads followed by separation on MACS Column, the eluted fraction contains non apoptotic sperm suitable for ICSI. Receives: Other: MACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euploidy rate
Defined as the proportion of euploid blastocysts
Measured: 15 days post ICSI
Aneuploidy rate
Defined as the proportion of aneuploid blastocysts
Measured: 15 days post ICSI
Low mosaic rate
Defined as the proportion of low mosaic blastocysts
Measured: 15 days post ICSI
High mosaic rate
Defined as the proportion of high mosaic blastocysts
Measured: 15 days post ICSI
Secondary outcomes (4)
Fertilization rate
Defined as the proportion of fertilizaed oocytes
Measured: 1 day
Cleavage rate
Defined as the proportion of cleaved embryos on day 3
Measured: 3 days
Blastocyst development rate
Defined as the proportion of blastocysts formed on day 5 or 6
Measured: 5-6 days
Blastocyst quality rate
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor
Measured: 5-6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm DNA FragmentationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eman Hasanen, BSc., Principal investigator, Ganin Fertility CenterManar Hozayen, MSc., Principal investigator, Ganin Fertility CenterAmr Elshimy, BSc., Principal investigator, Ganin Fertility CenterHanaa Alkhader, MBBS/MD, Principal investigator, Ganin Fertility CenterHosam Zaki, MSc, FRCOG, Study director, Ganin Fertility CenterYara Hazem, BP, Principal investigator, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494216
- Sponsor's protocol ID
- GFC-005
- Status last verified
- May 2024
- First submitted
- 6 Aug 2022
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates
- ClinicalTrials.gov ID
- NCT05494216
- Acronym / sponsor ID
- GFC-005
- Conditions
- Sperm DNA Fragmentation, Infertility
- Keywords
- Sperm selection, PICSI, MACS, Sperm DNA fragmentation, PGT-A, Euploidy rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 9 Aug 2022 (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.
Comparing different advanced sperm selection techniques like Physiological ICSI (PICSI) and magnetic activated cell sorting (MACS) in terms of the PGT-A outcomes of each arm blastocysts
Detailed description
Advanced sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with lower Sperm DNA fragmentation. Previous studies compared the pre-implantation embryo development parameters of those techniques, but none looked at comparing the PGT-A results or euploidy rates of the blastocysts derived from each sperm selection.
PGT-A cases will be randomized on the day of ICSI to the 2 assigned sperm selection techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICSI | Active comparator | Other: PICSISemen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Individual bound sperm selection is done followed y ICSI |
| MACS | Active comparator | Other: MACSSemen processing is done by double layer density gradient method. The resulted pellet is labeled with annexin V microbeads followed by separation on MACS Column, the eluted fraction contains non apoptotic sperm suitable for ICSI. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Case must have PGT-A for all of her blastocysts
- Males diagnosed with abnormal sperm DNA fragmentation index (> 20%).
- Normo responder (> 5 mature oocytes)
- Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of ICSI
Key exclusion criteria (7 listed)
- Leukocytospermia
- Presence of varicocele.
- Known genetic abnormality
- Use of sperm or oocyte donors
- Use of gestational carrier
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 |
|---|---|---|
| PICSISperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index | Other | PICSI |
| MACSSperm selection using MACS for selecting sperm with lower DNA fragmentation index | Other | MACS |
Primary outcome
Euploidy rate
Time frame: 15 days post ICSI
Defined as the proportion of euploid blastocysts
Aneuploidy rate
Time frame: 15 days post ICSI
Defined as the proportion of aneuploid blastocysts
Low mosaic rate
Time frame: 15 days post ICSI
Defined as the proportion of low mosaic blastocysts
High mosaic rate
Time frame: 15 days post ICSI
Defined as the proportion of high mosaic blastocysts
4 secondary outcomes
Fertilization rate
Time frame: 1 day
Cleavage rate
Time frame: 3 days
Blastocyst development rate
Time frame: 5-6 days
Blastocyst quality rate
Time frame: 5-6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Sperm DNA Fragmentation
Recruiting
Comparison of Two Different Sperm Processing Methods and Their Effects on Sperm DNA Fragmentation and Embryo Development
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Not yet recruiting
Randomized Non-inferiority Within-Patient Trial of Density Gradient Processing of Sequential Ejaculates Versus Centrifugation-free Sperm Separation Device for ICSI in Men With Elevated Sperm DNA Fragmentation.
Male
Active, not recruitingObservational study
Sperm Selection Strategies and Male-Factor Phenotypes in ICSI
Assisted Reproductive Technology, Assisted Reproductive Technology Outcomes
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Nordic Sperm DNA Study
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Recruiting
Effectiveness of Live Motile Sperm Sorting Device on IVF Outcomes in Advanced Paternal Age
Male Infertility, Advanced Paternal Age
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. This study is not recruiting at the moment.
Eman Hasanen, BSc. principal investigator
Ganin Fertility Center
Manar Hozayen, MSc. principal investigator
Ganin Fertility Center
Amr Elshimy, BSc. principal investigator
Ganin Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICSI and MACS in people with Sperm DNA Fragmentation and Infertility, run by Ganin Fertility Center at 1 site in Egypt.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Euploidy rate (time frame: 15 days post ICSI). The study lists 4 primary outcomes in all. 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 7 May 2024.