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PGT-A Evaluates Advanced Sperm Selection in Embryos From High Teratozoospermia Males

Next Generation Sequencing of Embryos for Testing the Efficacy of Advanced Sperm Selection Techniques in Males With High Teratozoospermia Index

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06231589
Enrollment
264
Registered
2024-01-30
Start date
2023-01-01
Completion date
2023-09-01
Last updated
2024-01-30

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

Conditions

Infertility, Sperm DNA Fragmentation, Teratozoospermia

Keywords

Sperm selection, Teratozoospermia index, Sperm DNA fragmentation, PGT-A, Euploidy rate

Brief 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 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.

Interventions

DEVICESperm Selection

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.

Sponsors

Ganin Fertility Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Males diagnosed with normal and high teratozoospermia index. 2. Males with Mild to moderate OTA (oligoteratoasthenozoospermia). 3. Males aged 18-60 years. 4. Female aged 18-40 years. 5. Case must have PGT-A for all of her blastocysts. 6. Normo responder (\> 5 mature oocytes). 7. 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.

Exclusion criteria

1. Leukocytospermia. 2. Presence of varicocele. 3. Known genetic abnormality. 4. Use of sperm or oocyte donors. 5. Use of gestational carrier. 6. Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection. 7. Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation.

Design outcomes

Primary

MeasureTime frameDescription
Fertilization rate1 dayDefined as the proportion of fertilizaed oocytes
Blastocyst development rate5-6 daysDefined as the proportion of blastocysts formed on day 5 or 6
Euploidy rate15 days post ICSIDefined as the proportion of euploid blastocysts
Aneuploidy rate15 days post ICSIDefined as the proportion of aneuploid blastocysts

Secondary

MeasureTime frameDescription
Low mosaic rate15 days post ICSIDefined as the proportion of low mosaic blastocysts
High mosaic rate15 days post ICSIDefined as the proportion of high mosaic blastocysts
Blastocyst quality rate5-6 daysDefined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026