Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2025-12-16 @ 10:25 PM
Study NCT ID:
NCT06231589
Status:
None
Last Update Posted:
2024-01-30 00:00:00
First Post:
2024-01-21 00:00:00
Brief Title:
PGT-A Evaluates Advanced Sperm Selection in Embryos From High Teratozoospermia Males
Sponsor:
Ganin Fertility Center
Organization:
Ganin Fertility Center
Study Overview
Official Title:
Next Generation Sequencing of Embryos for Testing the Efficacy of Advanced Sperm Selection Techniques in Males With High Teratozoospermia Index
Status:
None
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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 16 2 Males with high TZI and no sperm selection techniques are performed NO-SS group 63 males have TZI 18 and 3 Males with high TZI and sperm selection techniques are performed SS-group 90 males have TZI 18 The TZI was significantly P0000 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 P0000 The fertilization P0 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 5635346 as compared to the control group 5454324 and the NO-SS group 5745457 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None