Sperm DNA FragmentationNCT03398317
Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI
A study testing PICSI and MACS in people with Sperm DNA Fragmentation, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Sperm DNA Fragmentation
- What is being tested?
- PICSI and MACS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 30 Mar 2019
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males diagnosed of abnormal DNA fragmentation index ( > 19%).
- Males with mild to moderate OTA (oligoteratoasthenozoospermia).
- Male aged 18-60 years.
- Female aged 18-40 years.
- 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 oocyte retrieval
Who cannot join
- Males with normalDNA fragmentation index (<19%)at the initial assessment.
- Leukocytospermia
- Presence of varicocele.
- Known genetic abnormality
- Use of sperm donation or cryopreserved sperm
- Use of Oocyte donation
Show all 9Show fewer
- 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
Official title: PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial
On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose.
Read the detailed description
Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st trimester.
Sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best embryo quality and achieve higher ongoing pregnancy rates.
A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa without DNA fragmentation.
In order to determine which sperm selection technique is better for dealing with DNA fragmentation patients we need to study both techniques on two different groups of patients
- Conditions
- Sperm DNA Fragmentation
- Being tested
- PICSI, MACS
- Keywords
- SDF, DFI, sperm selection, PICSI, MACS
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 | Experimental | 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. Selecting an individual bound sperm with enhanced genetic and developmental integrity ensures that the sperm selected is the optimal sperm from the sample for oocyte injection 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 Oocyte injection. Receives: Other: MACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
Measured: 20 weeks of gestation
Secondary outcomes (5)
Comparison of cleavage rate
Defined as the proportion of cleaved embryos on day 3 over the injected oocytes
Measured: 3 days
Comparison of 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
Comparison of 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
Comparison of Pregnancy rate
Defined as clinical pregnancy per transfer
Measured: 14 days following embryo transfer
Comparison of implantation rate
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
Measured: 6- 8 weeks following embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Jan 2017
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, University of the Western Cape
- Responsible party
- Principal investigator, Eman Hasanen, Ganin Fertility Center
- Investigators
- Hosam Zaki, MSc, FRCOG, Study chair, Ganin Fertility Center, Cairo, EgyptEman Hasanen, BSc, Principal investigator, Ganin Fertility Center, Cairo, EgyptKhaled El Qusi, BSc, Principal investigator, Ganin Fertility Center, Cairo, EgyptAbd El Ghafar Hussin, BSc, Principal investigator, Ganin Fertility Center, Cairo, EgyptSalma El Tanbouly, BSc, Principal investigator, Ganin Fertility Center, Cairo, EgyptAshok Agarwal, PhD, Study director, American Center of Reproductive Medicine, Cleveland ClinicRalph Henkel, PhD, Principal investigator, University of the Western CapeHanaa Alkhader, Principal investigator, Ganin Fertility Center, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398317
- Sponsor's protocol ID
- GFC - 002
- Status last verified
- Jul 2020
- First submitted
- 7 Jan 2018
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benchaib M, Braun V, Lornage J, Hadj S, Salle B, Lejeune H, Guerin JF. Sperm DNA fragmentation decreases the pregnancy rate in an assisted reproductive technique. Hum Reprod. 2003 May;18(5):1023-8. doi: 10.1093/humrep/deg228.
PubMed 12721180Baldi and Muratori (2013) Genitic Damage in Human Spermatozoa. USA, NY : Springer Science & Business Media.
Hasanen E, Elqusi K, ElTanbouly S, Hussin AE, AlKhadr H, Zaki H, Henkel R, Agarwal A. PICSI vs. MACS for abnormal sperm DNA fragmentation ICSI cases: a prospective randomized trial. J Assist Reprod Genet. 2020 Oct;37(10):2605-2613. doi: 10.1007/s10815-020-01913-4. Epub 2020 Aug 8.
PubMed 32772268
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03398317
- Acronym / sponsor ID
- GFC - 002
- Conditions
- Sperm DNA Fragmentation
- Keywords
- SDF, DFI, sperm selection, PICSI, MACS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, University of the Western Cape
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 12 Jan 2018 (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.
On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose.
Detailed description
Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st trimester.
Sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best embryo quality and achieve higher ongoing pregnancy rates.
A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa without DNA fragmentation.
In order to determine which sperm selection technique is better for dealing with DNA fragmentation patients we need to study both techniques on two different groups of patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICSI | Experimental | 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. Selecting an individual bound sperm with enhanced genetic and developmental integrity ensures that the sperm selected is the optimal sperm from the sample for oocyte injection |
| 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 Oocyte injection. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males diagnosed of abnormal DNA fragmentation index ( > 19%).
- Males with mild to moderate OTA (oligoteratoasthenozoospermia).
- Male aged 18-60 years.
- Female aged 18-40 years.
- Normo responder ( > 5 mature oocytes)
Key exclusion criteria (9 listed)
- Males with normalDNA fragmentation index (<19%)at the initial assessment.
- Leukocytospermia
- Presence of varicocele.
- Known genetic abnormality
- Use of sperm donation or cryopreserved 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 |
|---|---|---|
| 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
Ongoing pregnancy rate
Time frame: 20 weeks of gestation
Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
5 secondary outcomes
Comparison of cleavage rate
Time frame: 3 days
Comparison of Blastulation rate
Time frame: 5-6 days
Comparison of Blastocyst quality rate
Time frame: 5-6 days
Comparison of Pregnancy rate
Time frame: 14 days following embryo transfer
Comparison of implantation rate
Time frame: 6- 8 weeks following embryo transfer
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 21 Jul 2020.
- Background: PubMed 12721180Benchaib M, Braun V, Lornage J, Hadj S, Salle B, Lejeune H, Guerin JF. Sperm DNA fragmentation decreases the pregnancy rate in an assisted reproductive technique. Hum Reprod. 2003 May;18(5):1023-8. doi: 10.1093/humrep/deg228.
- BackgroundBaldi and Muratori (2013) Genitic Damage in Human Spermatozoa. USA, NY : Springer Science & Business Media.
- Derived from this study: PubMed 32772268Hasanen E, Elqusi K, ElTanbouly S, Hussin AE, AlKhadr H, Zaki H, Henkel R, Agarwal A. PICSI vs. MACS for abnormal sperm DNA fragmentation ICSI cases: a prospective randomized trial. J Assist Reprod Genet. 2020 Oct;37(10):2605-2613. doi: 10.1007/s10815-020-01913-4. Epub 2020 Aug 8.
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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.
Hosam Zaki, MSc, FRCOG study chair
Ganin Fertility Center, Cairo, Egypt
Eman Hasanen, BSc principal investigator
Ganin Fertility Center, Cairo, Egypt
Khaled El Qusi, BSc principal investigator
Ganin Fertility Center, Cairo, Egypt
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, 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 9 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 21 Jul 2020. 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?
Ongoing pregnancy rate (time frame: 20 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398317, which also lists 3 linked publications.
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 Jul 2020.