CClinicalTrials.gg
CompletedNCT06476379Updated Aug 15, 2025

Can the Origin of Sperm Affect Embryo Ploidy in Patients With Severe Male Factor Infertility?

An interventional study of Testicular sperm extraction (TESE) and Ejaculate in Male Infertility, sponsored by Ganin Fertility Center. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-08-15.

Sponsored by Ganin Fertility Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Sex
All
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Study 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. 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.

02

Conditions studied

  • Male Infertility

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Keywords

  • ICSI
  • Male infertility
  • PGT-A
  • TESE
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In context

Infertility, Male

265 studies on the registry are indexed under Infertility, Male; 62 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 171 interventional studies indexed under Infertility, Male.

Browse Infertility, Male studies →

Lead sponsor

Ganin Fertility Center is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cases planned to have ICSI PGT-A cycles
  • Males diagnosed as severe male factor infertility
  • Normo responder female partners

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Ejaculate

    Patients within this arm will undergo ICSI utilizing ejaculated sperm.

    Other: Ejaculate

  • Active comparator
    Testicular

    Patients within this arm will undergo ICSI utilizing testicular sperm.

    Procedure: Testicular sperm extraction (TESE)

Interventions

  • ProcedureTesticular 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

  • OtherEjaculate

    Ejaculate processing for ICSI

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What researchers measure

Primary outcomes

  1. Euploidy rate

    Defined as the proportion of euploid blastocysts

    Time frame: 15 days post ICSI

  2. Aneuploidy rate

    Defined as the proportion of aneuploid blastocysts

    Time frame: 15 days post ICSI

  3. Low mosaic rate

    Defined as the proportion of low mosaic blastocysts

    Time frame: Time Frame: 15 days post ICSI

  4. High mosaic rate

    Defined as the proportion of high mosaic blastocysts

    Time frame: Time Frame: 15 days post ICSI

  5. Implantation rate

    defined as the percentage of successfully implanted embryos

    Time frame: 6-9 weeks post-embryo transfer

  6. Ongoing pregnancy rate

    defined as a positive heartbeat on ultrasound beyond 12 weeks of gestation

    Time frame: 12 weeks of gestation

  7. Miscarriage rate

    defined as pregnancy loss following confirmation of clinical pregnancy

    Time frame: after 6 weeks of gestation

  8. Clinical pregnancy rate

    defined as the presence of a fetal heartbeat or gestational sac 6-9 weeks post-embryo transfer

    Time frame: 6-9 weeks post-embryo transfer

Secondary outcomes

  1. Fertilization rate

    Defined as the proportion of fertilizaed oocytes

    Time frame: 1 day

  2. Cleavage rate

    Defined as the proportion of cleaved embryos on day 3

    Time frame: 3 days

  3. Blastocyst development rate

    Defined as the proportion of blastocysts formed on day 5 or 6

    Time frame: 5-6 days

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Study locations

1 site
  • Ganin Fertility Center
    Cairo, Maadi 11728, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06476379
Lead sponsor
Ganin Fertility Center
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Jun 25, 2024
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025
Last update
Aug 15, 2025

Study contacts

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
Mohamed Abbas
study chair · Cairo University
Nahla Osama, Phd
study chair · Faculty of Science, Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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