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Completed

NCT Number: NCT06476379

Can the Origin of Sperm 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.

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ganin Fertility Center

Cairo, Maadi, 11728, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Testicular sperm extraction (TESE)

Procedure

Surgical procedure used to retrieve sperm directly from the testicles of men who have low sperm production or no sperm in their ejaculate

Ejaculate

Other

Ejaculate processing for ICSI

Primary outcomes

  1. Euploidy rate

    Time frame: 15 days post ICSI

    Defined as the proportion of euploid blastocysts

  2. Aneuploidy rate

    Time frame: 15 days post ICSI

    Defined as the proportion of aneuploid blastocysts

  3. Low mosaic rate

    Time frame: Time Frame: 15 days post ICSI

    Defined as the proportion of low mosaic blastocysts

  4. High mosaic rate

    Time frame: Time Frame: 15 days post ICSI

    Defined as the proportion of high mosaic blastocysts

  5. Implantation rate

    Time frame: 6-9 weeks post-embryo transfer

    defined as the percentage of successfully implanted embryos

  6. Ongoing pregnancy rate

    Time frame: 12 weeks of gestation

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

  7. Miscarriage rate

    Time frame: after 6 weeks of gestation

    defined as pregnancy loss following confirmation of clinical pregnancy

  8. 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

Secondary outcomes

  1. Fertilization rate

    Time frame: 1 day

    Defined as the proportion of fertilizaed oocytes

  2. Cleavage rate

    Time frame: 3 days

    Defined as the proportion of cleaved embryos on day 3

  3. Blastocyst development rate

    Time frame: 5-6 days

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

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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