in Vitro FertilizationNCT05943353
ICSI Using Pentoxifylline to Identify Viable Spermatozoa in Absolute Asthenozoospermia Patients
A study testing Pentoxifylline in people with in Vitro Fertilization, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
Absolute asthenozoospermia is a rare condition in men with an occurrence frequency of 1/5000 and greatly affects fertility product. Previous studies have shown that the ovum can be fertilized with live but immotile sperm. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- in Vitro Fertilization
- What is being tested?
- Pentoxifylline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteVietnam
- Study dates
- Aug 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sperm are completely immotile since PESA, TESE and MicroTESE
- Sperm are completely immotile after ejaculation
Who cannot join
- Oocyte maturation cycle in vitro
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
IVFMD, My Duc Hospital
Ho Chi Minh City
Tuong M Ho, M.D, +84903633377, tuongho.ivfmd@gmail.com
Tuan M Vo, Bsc, +849699616537, tuan.vm@myduchospital.vn
About this study
Official title: The Efficacy of Pentoxifylline on Sperm Selecting in Intracytoplasmic Sperm Injection (ICSI) of Absolute Asthenozoospermia
Absolute asthenozoospermia is a rare condition in men with an occurrence frequency of 1/5000 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.
Read the 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 1/5000 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 50.9%, P < 0.005) and a higher clinical pregnancy rate (38.3%) compared to 26.7%).
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 6/170 children in the control group (0% vs 3.5%, P=0.28). 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. 9.4%, P=1.00). 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.
- Conditions
- in Vitro Fertilization
- Being tested
- Pentoxifylline
- Keywords
- Pentoxifylline, Sperm selecting, Absolute asthenozoospermia, in Vitro Fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineOther
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. Therefore, the use of a sperm motility inducer such as PTX is a potential method to replace traditional ICSI sperm selection methods. Therefore, we 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 group | Role | What they receive |
|---|---|---|
| non-randomized trials | Other | Not described Receives: Other: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Total number of zygotes fertilized / total number of MII oocytes. zygote sperm is defined as a 2PN zygote at the time of testing fertilization17±1hours after ICSI
Measured: 16-18 hours after ICSI-PTX
Secondary outcomes (5)
Rate of good embryos on day 3
Total number of day 3 and type 2 embryos / total number of day 3 embryos at the time of embryo examination. Standard for grading embryo quality according to consensus Alpha and ESHRE (2011)
Measured: 67-69 hours
Rate of good embryos on day 5
Total number of day 5 embryos type 1 and type 2 / total number of day 3 embryos at the time of day 5 embryo examination. Standard for grading embryo quality according to consensus Alpha and ESHRE (2011)
Measured: 114-118 hours
Clinical pregnancy rate
Calculated by the number of clinical pregnancies / total number of patients participating in the study.
Measured: Clinical pregnancy is defined as the presence of an intrauterine gestational sac on ultrasound from 5 weeks of age
Progressing pregnancy rate
Calculated by the number of active pregnancies/total number of patients participating in the study.
Measured: An advanced pregnancy was defined as having at least one gestational sac with a fetal heartbeat up to 12 weeks of age
Miscarriage rate
Calculated by the number of cases of ongoing miscarriage / total number of patients participating in the study.
Measured: Progressive miscarriage is defined as: before the end of the 22nd week of pregnancy in which the fetus is no longer viable and expelled from the uterus.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Vitro FertilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuong M Ho, M.D, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943353
- Sponsor's protocol ID
- 07/23/DD-BVMD
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pentoxifylline on Sperm Selecting in Intracytoplasmic Sperm Injection (ICSI) of Absolute Asthenozoospermia
- ClinicalTrials.gov ID
- NCT05943353
- Acronym / sponsor ID
- 07/23/DD-BVMD
- Conditions
- in Vitro Fertilization
- Keywords
- Pentoxifylline, Sperm selecting, Absolute asthenozoospermia, in Vitro Fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Absolute asthenozoospermia is a rare condition in men with an occurrence frequency of 1/5000 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 1/5000 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 50.9%, P < 0.005) and a higher clinical pregnancy rate (38.3%) compared to 26.7%).
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 6/170 children in the control group (0% vs 3.5%, P=0.28). 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. 9.4%, P=1.00). 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-randomized trials | Other | Other: Pentoxifylline |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Sperm are completely immotile since PESA, TESE and MicroTESE
- Sperm are completely immotile after ejaculation
Key exclusion criteria (1 listed)
- Oocyte maturation cycle in vitro
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PentoxifyllineProminently, 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. Therefore, the use of a sperm motility inducer such as PTX is a potential method to replace traditional ICSI sperm selection methods. Therefore, we 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. | Other | non-randomized trials |
Primary outcome
Fertilization rate
Time frame: 16-18 hours after ICSI-PTX
Total number of zygotes fertilized / total number of MII oocytes. zygote sperm is defined as a 2PN zygote at the time of testing fertilization17±1hours after ICSI
5 secondary outcomes
Rate of good embryos on day 3
Time frame: 67-69 hours
Rate of good embryos on day 5
Time frame: 114-118 hours
Clinical pregnancy rate
Time frame: Clinical pregnancy is defined as the presence of an intrauterine gestational sac on ultrasound from 5 weeks of age
Progressing pregnancy rate
Time frame: An advanced pregnancy was defined as having at least one gestational sac with a fetal heartbeat up to 12 weeks of age
Miscarriage rate
Time frame: Progressive miscarriage is defined as: before the end of the 22nd week of pregnancy in which the fetus is no longer viable and expelled from the uterus.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuong M Ho, M.D principal investigator
Mỹ Đức Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline in people with in Vitro Fertilization, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuong M Ho, M.D (+84903633377, tuongho.ivfmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: 16-18 hours after ICSI-PTX). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.