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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06476379
Enrollment
100
Registered
2024-06-26
Start date
2024-06-25
Completion date
2025-04-30
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Keywords

ICSI, Male infertility, PGT-A, TESE

Brief 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.

Interventions

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

Sponsors

Ganin Fertility Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rate6-9 weeks post-embryo transferdefined as the presence of a fetal heartbeat or gestational sac 6-9 weeks post-embryo transfer
Euploidy rate15 days post ICSIDefined as the proportion of euploid blastocysts
Ongoing pregnancy rate12 weeks of gestationdefined as a positive heartbeat on ultrasound beyond 12 weeks of gestation
Miscarriage rateafter 6 weeks of gestationdefined as pregnancy loss following confirmation of clinical pregnancy
Aneuploidy rate15 days post ICSIDefined as the proportion of aneuploid blastocysts
Low mosaic rateTime Frame: 15 days post ICSIDefined as the proportion of low mosaic blastocysts
High mosaic rateTime Frame: 15 days post ICSIDefined as the proportion of high mosaic blastocysts
Implantation rate6-9 weeks post-embryo transferdefined as the percentage of successfully implanted embryos

Secondary

MeasureTime frameDescription
Cleavage rate3 daysDefined as the proportion of cleaved embryos on day 3
Blastocyst development rate5-6 daysDefined as the proportion of blastocysts formed on day 5 or 6
Fertilization rate1 dayDefined as the proportion of fertilizaed oocytes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026