TeratozoospermiaNCT06231589
PGT-A Evaluates Advanced Sperm Selection in Embryos From High Teratozoospermia Males
A study testing Sperm Selection in people with Teratozoospermia and Sperm DNA Fragmentation, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
In this study of 264 couples, sperm selection techniques in males with high teratozoospermia index and sperm DNA fragmentation significantly increased fertilization, blastocyst development rates, and maintained comparable embryo euploidy rates through preimplantation genetic testing, suggesting the efficiency of these… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Teratozoospermia, Sperm DNA Fragmentation, Infertility
- What is being tested?
- Sperm Selection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Sep 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males diagnosed with normal and high teratozoospermia index.
- Males with Mild to moderate OTA (oligoteratoasthenozoospermia).
- Males aged 18-60 years.
- Female aged 18-40 years.
- Case must have PGT-A for all of her blastocysts.
- 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
Official title: Next Generation Sequencing of Embryos for Testing the Efficacy of Advanced Sperm Selection Techniques in Males With High Teratozoospermia Index
In this study of 264 couples, sperm selection techniques in males with high teratozoospermia index and sperm DNA fragmentation significantly increased fertilization, blastocyst development rates, and maintained comparable embryo euploidy rates through preimplantation genetic testing, suggesting the efficiency of these techniques in improving assisted reproductive outcomes.
Read the detailed description
Couples seeking infertility treatment are becoming more frequent. Paternal factor shows one of the infertility causes which may have a negative impact on reproductive outcomes. Intracytoplasmic sperm injection (ICSI) is thought to be the most effective way to treat infertility. Sperm morphology evaluation is a reliable predictor of male fertility while teratozoospermia index (TZI) is a unique expression of sperm morphological assessment. A higher rate of abnormal sperm morphology tends to have higher sperm chromosomal abnormality rates. The choice of high-quality sperm through sperm selection techniques is expected to improve ICSI outcomes. In this study, a total number of 264 couples were included and divided into 3 groups: (1) Males have normal TZI (Control group: 111 males have TZI <1.6), (2) Males with high TZI and no sperm selection techniques are performed (NO-SS group: 63 males have TZI >1.8), and (3) Males with high TZI and sperm selection techniques are performed (SS-group: 90 males have TZI >1.8). The TZI was significantly (P<0.000) higher in the NO-SS and SS-group as compared to the control group. The percentage of sperm DNA fragmentation SDF in the males of the SS group was significantly higher than the controls and NO-SS group (P=0.000). The fertilization (P=0. 039) and blastocyst development rates (P= 0. 041) are significantly higher in the SS group as compared to the NO-SS group in females aged <35. A total of 1072 embryos were tested for preimplantation genetic testing for aneuploidy using NGS, although higher SDF in the males of the SS group, the embryo euploidy rates show that there is no significant difference between the SS group (56.35±3.46%) as compared to the control group (54.54±3.24%) and the NO-SS group (57.45±4.57%). In general, we found that sperm selection techniques are efficient techniques in increasing fertilization, blastocyst development rates, and euploidy rate in males with high teratozoospermia index and sperm DNA fragmentation combined.
- Conditions
- Teratozoospermia, Sperm DNA Fragmentation, Infertility
- Being tested
- Sperm Selection
- Keywords
- Sperm selection, Teratozoospermia index, Sperm DNA fragmentation, PGT-A, Euploidy rate
- Medical subject headings
- Teratozoospermia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm SelectionDevice
Sperm selection using physiological intracytoplasmic sperm injection (PICSI dish) or magnetic-activated cell sorting (MACS) for selecting sperm with high-quality, better morphology and lower DNA fragmentation.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 111 Males have normal Teratozoospermia index (TZI) less than 1.6. Semen processing is done by double layer density gradient method only. |
| Sperm selection group PICSI or MACS (SS-Group) | Experimental | 90 Males with high TZI and sperm selection techniques such as PICSI or MACS are performed. Semen processing is done by double layer density gradient method followed by:
(1) In case of PICSI: 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 by ICSI.
or (2) In case of MACS: 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: Device: Sperm Selection |
| No sperm selection group (NO SS-Group) | No intervention | 63 Males with high TZI more than 1.8 and no sperm selection techniques are performed. Semen processing is done by double layer density gradient method only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Defined as the proportion of fertilizaed oocytes
Measured: 1 day
Blastocyst development rate
Defined as the proportion of blastocysts formed on day 5 or 6
Measured: 5-6 days
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
Secondary outcomes (3)
Blastocyst quality rate
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor
Measured: 5-6 days
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TeratozoospermiaStudies 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Nasreldin Abdelmagied Ali, Ganin Fertility Center
- Investigators
- Mohamed Nasreldin, MSc., Study chair, Ganin Fertility CenterHanan Ramadan, PhD, Principal investigator, Cairo UniversityMaiada Moustafa, PhD, Principal investigator, Helwan UniversityMohamed Abas, MBB, Principal investigator, Cairo UniversityHosam Zaki, MSc, FRCOG, Study director, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231589
- Sponsor's protocol ID
- GFC-008
- Status last verified
- Jan 2024
- First submitted
- 21 Jan 2024
- Last updated
- 30 Jan 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation Sequencing of Embryos for Testing the Efficacy of Advanced Sperm Selection Techniques in Males With High Teratozoospermia Index
- ClinicalTrials.gov ID
- NCT06231589
- Acronym / sponsor ID
- GFC-008
- Conditions
- Teratozoospermia, Sperm DNA Fragmentation, Infertility
- Keywords
- Sperm selection, Teratozoospermia index, Sperm DNA fragmentation, PGT-A, Euploidy rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 30 Jan 2024 (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.
In this study of 264 couples, sperm selection techniques in males with high teratozoospermia index and sperm DNA fragmentation significantly increased fertilization, blastocyst development rates, and maintained comparable embryo euploidy rates through preimplantation genetic testing, suggesting the efficiency of these techniques in improving assisted reproductive outcomes.
Detailed description
Couples seeking infertility treatment are becoming more frequent. Paternal factor shows one of the infertility causes which may have a negative impact on reproductive outcomes. Intracytoplasmic sperm injection (ICSI) is thought to be the most effective way to treat infertility. Sperm morphology evaluation is a reliable predictor of male fertility while teratozoospermia index (TZI) is a unique expression of sperm morphological assessment. A higher rate of abnormal sperm morphology tends to have higher sperm chromosomal abnormality rates. The choice of high-quality sperm through sperm selection techniques is expected to improve ICSI outcomes. In this study, a total number of 264 couples were included and divided into 3 groups: (1) Males have normal TZI (Control group: 111 males have TZI <1.6), (2) Males with high TZI and no sperm selection techniques are performed (NO-SS group: 63 males have TZI >1.8), and (3) Males with high TZI and sperm selection techniques are performed (SS-group: 90 males have TZI >1.8). The TZI was significantly (P<0.000) higher in the NO-SS and SS-group as compared to the control group. The percentage of sperm DNA fragmentation SDF in the males of the SS group was significantly higher than the controls and NO-SS group (P=0.000). The fertilization (P=0. 039) and blastocyst development rates (P= 0. 041) are significantly higher in the SS group as compared to the NO-SS group in females aged <35. A total of 1072 embryos were tested for preimplantation genetic testing for aneuploidy using NGS, although higher SDF in the males of the SS group, the embryo euploidy rates show that there is no significant difference between the SS group (56.35±3.46%) as compared to the control group (54.54±3.24%) and the NO-SS group (57.45±4.57%). In general, we found that sperm selection techniques are efficient techniques in increasing fertilization, blastocyst development rates, and euploidy rate in males with high teratozoospermia index and sperm DNA fragmentation combined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –111 Males have normal Teratozoospermia index (TZI) less than 1.6. Semen processing is done by double layer density gradient method only. |
| Sperm selection group PICSI or MACS (SS-Group) | Experimental | Device: Sperm Selection90 Males with high TZI and sperm selection techniques such as PICSI or MACS are performed. Semen processing is done by double layer density gradient method followed by: (1) In case of PICSI: 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 by ICSI. or (2) In case of MACS: 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. |
| No sperm selection group (NO SS-Group) | No intervention | –63 Males with high TZI more than 1.8 and no sperm selection techniques are performed. Semen processing is done by double layer density gradient method only. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males diagnosed with normal and high teratozoospermia index.
- Males with Mild to moderate OTA (oligoteratoasthenozoospermia).
- Males aged 18-60 years.
- Female aged 18-40 years.
- Case must have PGT-A for all of her blastocysts.
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 |
|---|---|---|
| Sperm SelectionSperm selection using physiological intracytoplasmic sperm injection (PICSI dish) or magnetic-activated cell sorting (MACS) for selecting sperm with high-quality, better morphology and lower DNA fragmentation. | Device | Sperm selection group PICSI or MACS (SS-Group) |
Primary outcome
Fertilization rate
Time frame: 1 day
Defined as the proportion of fertilizaed oocytes
Blastocyst development rate
Time frame: 5-6 days
Defined as the proportion of blastocysts formed on day 5 or 6
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
3 secondary outcomes
Blastocyst quality rate
Time frame: 5-6 days
Low mosaic rate
Time frame: 15 days post ICSI
High mosaic rate
Time frame: 15 days post ICSI
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 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Nasreldin, MSc. study chair
Ganin Fertility Center
Hanan Ramadan, PhD principal investigator
Cairo University
Maiada Moustafa, PhD principal investigator
Helwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sperm Selection in people with Teratozoospermia and 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 7 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 30 Jan 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?
Fertilization rate (time frame: 1 day). 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 30 Jan 2024.