Male InfertilityNCT04496232
Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
A study testing PICSI and Second ejaculate in people with Male Infertility, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Male Infertility
- What is being tested?
- PICSI and Second ejaculate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Dec 2021
- 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
- Male partner with abnormal sperm DNA fragmentation index (>20%) by TUNEL assay
- Male partner with at least 1 million progressive motile count
- Male aged 18-50 years
- Male with adjusted sexual abstinence days (1-2 days)
- Female aged 18-37 years
- Normo-responder females (at least 5 mature oocytes)
Who cannot join
- Leukocytospermia
- Varicocele
- Known genetic abnormality
- Use of oocyte or sperm donors
- Use of a gestational carrier
- Presence of any endometrial factors that can affect embryo implantation
- Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.
Read the detailed description
Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.
- Conditions
- Male Infertility
- Being tested
- PICSI, Second ejaculate
- Keywords
- Sperm DNA fragmentation, Second ejaculate, Sperm Selection, PICSI
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICSIDevice
Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate
Second ejaculateOther
Semen processing by density gradient centrifugation for the second ejaculate
| Study group | Role | What they receive |
|---|---|---|
| Normal SDF | No intervention | Using routine semen processing method |
| Physiological ICSI (PICSI) | Active comparator | Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI Receives: Device: PICSI |
| Second ejaculate | Active comparator | Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI Receives: Other: Second ejaculate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Defined as the proportion of fertilized oocytes over the injected oocytes.
Measured: 16-19 hours
Cleavage rate
Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.
Measured: 3 days
Blastulation rate
Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.
Measured: 5-6 days
Blastocyst quality rate
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair, or bad in terms of percentage of the total formed blastocysts.
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 posted3 Aug 2020
- Study start1 Aug 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hasanen, Ganin Fertility Center
- Investigators
- Eman Hasanen, Principal investigator, Ganin Fertility CenterRadwa Omar, Principal investigator, Ganin Fertility CenterHanaa Alkhader, Principal investigator, Ganin Fertility CenterHosam Zaki, MSc, FRCOG, Study director, Ganin Fertility CenterManar Hozayen, MSc., Principal investigator, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496232
- Sponsor's protocol ID
- GFC-004
- Status last verified
- Aug 2022
- First submitted
- 29 Jul 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04496232
- Acronym / sponsor ID
- GFC-004
- Conditions
- Male Infertility
- Keywords
- Sperm DNA fragmentation, Second ejaculate, Sperm Selection, PICSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 Aug 2020 (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 second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.
Detailed description
Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal SDF | No intervention | –Using routine semen processing method |
| Physiological ICSI (PICSI) | Active comparator | Device: PICSISperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI |
| Second ejaculate | Active comparator | Other: Second ejaculateUsing the second ejaculate as a way of reducing SDF in the semen sample used for ICSI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male partner with abnormal sperm DNA fragmentation index (>20%) by TUNEL assay
- Male partner with at least 1 million progressive motile count
- Male aged 18-50 years
- Male with adjusted sexual abstinence days (1-2 days)
- Female aged 18-37 years
Key exclusion criteria (7 listed)
- Leukocytospermia
- Varicocele
- Known genetic abnormality
- Use of oocyte or sperm donors
- Use of a 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 |
|---|---|---|
| PICSISemen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate | Device | Physiological ICSI (PICSI) |
| Second ejaculateSemen processing by density gradient centrifugation for the second ejaculate | Other | Second ejaculate |
Primary outcome
Fertilization rate
Time frame: 16-19 hours
Defined as the proportion of fertilized oocytes over the injected oocytes.
Cleavage rate
Time frame: 3 days
Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.
Blastulation rate
Time frame: 5-6 days
Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.
Blastocyst quality rate
Time frame: 5-6 days
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair, or bad in terms of percentage of the total formed blastocysts.
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 9 Aug 2022.
- Individual participant dataSharing planned: Yes
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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 principal investigator
Ganin Fertility Center
Radwa Omar principal investigator
Ganin Fertility Center
Hanaa Alkhader 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 Second ejaculate in people with Male 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 6 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 9 Aug 2022. 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?
Fertilization rate (time frame: 16-19 hours). 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 9 Aug 2022.