Clinical Trials Directory

Trials / Completed

CompletedNCT06231589

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
Phase
N/A
Study type
Interventional
Enrollment
264 (actual)
Sponsor
Ganin Fertility Center · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICESperm SelectionSperm 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.

Timeline

Start date
2023-01-01
Primary completion
2023-09-01
Completion
2023-09-01
First posted
2024-01-30
Last updated
2024-01-30

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06231589. Inclusion in this directory is not an endorsement.