Male InfertilityNCT06476379
Can the Origin of Sperm Affect Embryo Ploidy in Patients With Severe Male Factor Infertility?
A study testing Testicular sperm extraction (TESE) and Ejaculate in people with Male Infertility, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
There is evidence indicating that sperm plays a role in determining blastocyst ploidy status. In our study, we aim to compare the outcomes of preimplantation genetic testing for aneuploidy (PGT-A) and the subsequent clinical outcomes following transfers of euploid embryos. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Male Infertility
- What is being tested?
- Testicular sperm extraction (TESE) and Ejaculate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2024to 30 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cases planned to have ICSI PGT-A cycles
- Males diagnosed as severe male factor infertility
- Normo responder female partners
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: Can the Origin of Sperm - Ejaculated or Testicular- Affect Embryo Ploidy in Patients With Severe Male Factor Infertility?
There is evidence indicating that sperm plays a role in determining blastocyst ploidy status. In our study, we aim to compare the outcomes of preimplantation genetic testing for aneuploidy (PGT-A) and the subsequent clinical outcomes following transfers of euploid embryos. This comparison will be conducted between cases where ejaculated sperm and cases where testicular sperm were used for intracytoplasmic sperm injection (ICSI), specifically focusing on severe male factor infertility patients.
- Conditions
- Male Infertility
- Being tested
- Testicular sperm extraction (TESE), Ejaculate
- Keywords
- ICSI, Male infertility, PGT-A, TESE
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testicular sperm extraction (TESE)Procedure or surgery
Surgical procedure used to retrieve sperm directly from the testicles of men who have low sperm production or no sperm in their ejaculate
EjaculateOther
Ejaculate processing for ICSI
| Study group | Role | What they receive |
|---|---|---|
| Ejaculate | Active comparator | Patients within this arm will undergo ICSI utilizing ejaculated sperm. Receives: Other: Ejaculate |
| Testicular | Active comparator | Patients within this arm will undergo ICSI utilizing testicular sperm. Receives: Procedure: Testicular sperm extraction (TESE) |
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: Time Frame: 15 days post ICSI
High mosaic rate
Defined as the proportion of high mosaic blastocysts
Measured: Time Frame: 15 days post ICSI
Implantation rate
defined as the percentage of successfully implanted embryos
Measured: 6-9 weeks post-embryo transfer
Ongoing pregnancy rate
defined as a positive heartbeat on ultrasound beyond 12 weeks of gestation
Measured: 12 weeks of gestation
Miscarriage rate
defined as pregnancy loss following confirmation of clinical pregnancy
Measured: after 6 weeks of gestation
Clinical pregnancy rate
defined as the presence of a fetal heartbeat or gestational sac 6-9 weeks post-embryo transfer
Measured: 6-9 weeks post-embryo transfer
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start25 Jun 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eman Hasanen, Principal investigator, Ganin Fertility CenterHosam Zaki, FRCOG, Study chair, Ganin Fertility CenterRefaat Gabre, PhD, Study director, Faculty of Science, Cairo UniversityMohamed Abbas, Study chair, Cairo UniversityNahla Osama, Phd, Study chair, Faculty of Science, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476379
- Sponsor's protocol ID
- GFC-009
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Origin of Sperm - Ejaculated or Testicular- Affect Embryo Ploidy in Patients With Severe Male Factor Infertility?
- ClinicalTrials.gov ID
- NCT06476379
- Acronym / sponsor ID
- GFC-009
- Conditions
- Male Infertility
- Keywords
- ICSI, Male infertility, PGT-A, TESE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 26 Jun 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.
There is evidence indicating that sperm plays a role in determining blastocyst ploidy status. In our study, we aim to compare the outcomes of preimplantation genetic testing for aneuploidy (PGT-A) and the subsequent clinical outcomes following transfers of euploid embryos. This comparison will be conducted between cases where ejaculated sperm and cases where testicular sperm were used for intracytoplasmic sperm injection (ICSI), specifically focusing on severe male factor infertility patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ejaculate | Active comparator | Other: EjaculatePatients within this arm will undergo ICSI utilizing ejaculated sperm. |
| Testicular | Active comparator | Procedure: Testicular sperm extraction (TESE)Patients within this arm will undergo ICSI utilizing testicular sperm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Cases planned to have ICSI PGT-A cycles
- Males diagnosed as severe male factor infertility
- Normo responder female partners
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 |
|---|---|---|
| Testicular sperm extraction (TESE)Surgical procedure used to retrieve sperm directly from the testicles of men who have low sperm production or no sperm in their ejaculate | Procedure or surgery | Testicular |
| EjaculateEjaculate processing for ICSI | Other | Ejaculate |
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: Time Frame: 15 days post ICSI
Defined as the proportion of low mosaic blastocysts
High mosaic rate
Time frame: Time Frame: 15 days post ICSI
Defined as the proportion of high mosaic blastocysts
Implantation rate
Time frame: 6-9 weeks post-embryo transfer
defined as the percentage of successfully implanted embryos
Ongoing pregnancy rate
Time frame: 12 weeks of gestation
defined as a positive heartbeat on ultrasound beyond 12 weeks of gestation
Miscarriage rate
Time frame: after 6 weeks of gestation
defined as pregnancy loss following confirmation of clinical pregnancy
Clinical pregnancy rate
Time frame: 6-9 weeks post-embryo transfer
defined as the presence of a fetal heartbeat or gestational sac 6-9 weeks post-embryo transfer
3 secondary outcomes
Fertilization rate
Time frame: 1 day
Cleavage rate
Time frame: 3 days
Blastocyst development 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 15 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Male Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
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Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
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Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
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
Hosam Zaki, FRCOG study chair
Ganin Fertility Center
Refaat Gabre, PhD study director
Faculty of Science, Cairo 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 Testicular sperm extraction (TESE) and 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 3 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 15 Aug 2025. 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 8 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 15 Aug 2025.