Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05943353
Status:
RECRUITING
Last Update Posted:
2023-07-13
First Post:
2023-07-03
Brief Title:
ICSI Using Pentoxifylline to Identify Viable Spermatozoa in Absolute Asthenozoospermia Patients
Sponsor:
Mỹ Đức Hospital
Organization:
Mỹ Đức Hospital
Study Overview
Official Title:
The Efficacy of Pentoxifylline on Sperm Selecting in Intracytoplasmic Sperm Injection ICSI of Absolute Asthenozoospermia
Status:
RECRUITING
Status Verified Date:
2023-07
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:
Absolute asthenozoospermia is a rare condition in men with an occurrence frequency of 15000 and greatly affects fertility product Previous studies have shown that the ovum can be fertilized with live but immotile sperm However the selection of live sperm for ICSI in immotile sperm samples is challenging for embryologists Prominently Pentoxyfilline PTX is a methylxanthine derivative is an inhibitor of phosphodiesterase activity and increases intracellular cAMP levels which play an important role in sperm motility In recent years many studies have demonstrated the effectiveness of PTX for the group of spermatozoa sperm carrying severe abnormalities In Vietnam the application of PTX in ICSI has not yet been done in assisted reproductive centers It is necessary to evaluate the effectiveness of PTX on ICSI treatment results in order to replace traditional methods and optimize treatment outcomes for patients
Detailed Description:
Sperm motility is an important factor in sperm selection for intracytoplasmic sperm injection Intracytoplasmic Sperm Injection ICSI affects the success of ICSI cycles In cases of severe male factor infertility if motile sperm are still observed ICSI still has the potential to help improve fertilization rates and treatment outcomes for patients In contrast the absence of motile sperm after ejaculation greatly affects the fertilization rate and the success of the ICSI cycle
Absolute asthenozoospermia is a rare condition in men with an occurrence frequency of 15000 and greatly affects fertility product In addition complete immobility of sperm was also observed in cases of sperm collection from epididymal surgery Percutaneous Epididymal Sperm Aspiration PESA or obtained from the testicles Testicular Sperm Extraction TESE The characteristics of sperm samples obtained from the procedure are usually a high percentage of poor motility or complete immobility and cryopreservation of sperm may affect sperm motility and viability especially for sperm samples from surgical collection
Previous studies have shown that the ovum can be fertilized with live but immotile sperm However the selection of live sperm for ICSI in immotile sperm samples is challenging for embryologists Currently the methods performed in this case include the hypo-osmotic swelling test HOS test the sperm tail flexibility test STFT and laser-assisted immotile sperm selection LAISS However traditional methods such as HOS test and STFT have the common disadvantage of long operation time and the result of sperm selection can be false positive LAISS method is reported to be highly effective but still has some negative effects disadvantages in terms of operation time high operating costs and requiring professional qualifications Besides the above methods the use of chemical inducers for sperm selection has received more and more attention in recent years Prominently Pentoxyfilline PTX is a methylxanthine derivative is an inhibitor of phosphodiesterase activity and increases intracellular cAMP levels which play an important role in sperm motility The ability of PTX to improve sperm motility was first recognized in the study of Turner et al 1978 One of the advantages of PTX is that it significantly reduces the time to find and select motile sperm in cases of completely immotile sperm In recent years many studies have demonstrated the effectiveness of PTX for the group of spermatozoa sperm carrying severe abnormalities The study of Kovacic et al 2006 compared the embryology results of two groups of ICSI from spermatozoa with and without PTX use in addition the average ICSI time of 1 cycle from time to time initiation of sperm selection and immobilization until completion of the ICSI procedure were evaluated in two groups PTX shortened ICSI time mean 30 minutes compared with the control group mean 120 minutes In addition when compared with the group that did not use PTX the group that used PTX had higher fertilization results 66 vs 509 P 0005 and a higher clinical pregnancy rate 383 compared to 267
In addition the use of PTX is assessed to have no negative impact on sperm and the health of live children Stephanie et al 2021 evaluated the effects of PTX use on the development and behavior of 3-year-old children born from the ICSI cycle No abnormal growth was observed among 8 children born from ICSI-PTX cycle compared with 6170 children in the control group 0 vs 35 P028 In addition there was no difference in the percentage of children with behavioral abnormalities in the ICSI-PTX group compared with the control group 0 vs 94 P100 The study showed that PTX has potential applications in ICSI to improve sperm motility in cases of complete immobility helping to improve treatment outcomes for patients Therefore the use of a sperm motility inducer such as PTX is a potential method to replace traditional ICSI sperm selection methods In Vietnam the application of PTX in ICSI has not yet been done in assisted reproductive centers It is necessary to evaluate the effectiveness of PTX on ICSI treatment results in order to replace traditional methods and optimize treatment outcomes for patients Therefore the investigators performed this study with the aim to evaluate the effectiveness of PTX to select sperm in ICSI on the group of sperm that were completely immotile after ejaculation and obtained from the procedure
Absolute asthenozoospermia is a rare condition in men with an occurrence frequency of 15000 and greatly affects fertility product In addition complete immobility of sperm was also observed in cases of sperm collection from epididymal surgery Percutaneous Epididymal Sperm Aspiration PESA or obtained from the testicles Testicular Sperm Extraction TESE The characteristics of sperm samples obtained from the procedure are usually a high percentage of poor motility or complete immobility and cryopreservation of sperm may affect sperm motility and viability especially for sperm samples from surgical collection
Previous studies have shown that the ovum can be fertilized with live but immotile sperm However the selection of live sperm for ICSI in immotile sperm samples is challenging for embryologists Currently the methods performed in this case include the hypo-osmotic swelling test HOS test the sperm tail flexibility test STFT and laser-assisted immotile sperm selection LAISS However traditional methods such as HOS test and STFT have the common disadvantage of long operation time and the result of sperm selection can be false positive LAISS method is reported to be highly effective but still has some negative effects disadvantages in terms of operation time high operating costs and requiring professional qualifications Besides the above methods the use of chemical inducers for sperm selection has received more and more attention in recent years Prominently Pentoxyfilline PTX is a methylxanthine derivative is an inhibitor of phosphodiesterase activity and increases intracellular cAMP levels which play an important role in sperm motility The ability of PTX to improve sperm motility was first recognized in the study of Turner et al 1978 One of the advantages of PTX is that it significantly reduces the time to find and select motile sperm in cases of completely immotile sperm In recent years many studies have demonstrated the effectiveness of PTX for the group of spermatozoa sperm carrying severe abnormalities The study of Kovacic et al 2006 compared the embryology results of two groups of ICSI from spermatozoa with and without PTX use in addition the average ICSI time of 1 cycle from time to time initiation of sperm selection and immobilization until completion of the ICSI procedure were evaluated in two groups PTX shortened ICSI time mean 30 minutes compared with the control group mean 120 minutes In addition when compared with the group that did not use PTX the group that used PTX had higher fertilization results 66 vs 509 P 0005 and a higher clinical pregnancy rate 383 compared to 267
In addition the use of PTX is assessed to have no negative impact on sperm and the health of live children Stephanie et al 2021 evaluated the effects of PTX use on the development and behavior of 3-year-old children born from the ICSI cycle No abnormal growth was observed among 8 children born from ICSI-PTX cycle compared with 6170 children in the control group 0 vs 35 P028 In addition there was no difference in the percentage of children with behavioral abnormalities in the ICSI-PTX group compared with the control group 0 vs 94 P100 The study showed that PTX has potential applications in ICSI to improve sperm motility in cases of complete immobility helping to improve treatment outcomes for patients Therefore the use of a sperm motility inducer such as PTX is a potential method to replace traditional ICSI sperm selection methods In Vietnam the application of PTX in ICSI has not yet been done in assisted reproductive centers It is necessary to evaluate the effectiveness of PTX on ICSI treatment results in order to replace traditional methods and optimize treatment outcomes for patients Therefore the investigators performed this study with the aim to evaluate the effectiveness of PTX to select sperm in ICSI on the group of sperm that were completely immotile after ejaculation and obtained from the procedure
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?:
False
Is an FDA AA801 Violation?:
None