InfertilityPhase 4PXNNCT02051075
Fertilizations With Immotile Sperm: Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation
A Phase 4 study testing PXN sperm treatment and Sperm activation with PXN and oocyte activation in people with Infertility, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Immotile sperm is a rather frequent problem encountered in IVF patients. Treatment is usually based on inducing motility with pentoxyphylline (PXN) followed by ICSI. However, fertilization rate with this method is still lower compared with ICSI using motile sperm. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Infertility
- What is being tested?
- PXN sperm treatment and Sperm activation with PXN and oocyte activation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 4
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Women up to 35 years of age
- immotile sperm
- At least 6 mature eggs
Who cannot join
- globozoospermia
- "Freeze all" cycles because of OHSS risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Compare Fertilizations With Immotile Sperm After Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation
Immotile sperm is a rather frequent problem encountered in IVF patients. Treatment is usually based on inducing motility with pentoxyphylline (PXN) followed by ICSI. However, fertilization rate with this method is still lower compared with ICSI using motile sperm. One of the reasons for that is the immotile sperm inability to activate the oocyte Our research hypothesis is that better fertilization rate can be accomplished in these cases by combining PXN sperm activation with Ca ionophore oocyte activation.
- Conditions
- Infertility
- Being tested
- PXN sperm treatment, Sperm activation with PXN and oocyte activation
- Keywords
- IVF, ICSI, Asthenospermia, pentoxyphylline, Spermatozoa
- Medical subject headings
- Infertility, Asthenozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXN sperm treatmentBiological
immotile sperm activation with PXN
Sperm activation with PXN and oocyte activationBiological
| Study group | Role | What they receive |
|---|---|---|
| PXN only | Active comparator | Sperm activation with PXN before ICSI Receives: Biological: PXN sperm treatment |
| PXN activation and oocyte activation | Experimental | Sperm activation with PXN and oocyte activation Receives: Biological: Sperm activation with PXN and oocyte activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
Demonstration of fetal heart activity 1 month post oocyte retrieval.
Measured: One month post oocyte retrieval
Secondary outcomes (1)
Fertilization rate
Normal, 2 pronuclei, zygote one day post ICSI
Measured: One day post oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Kol MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051075
- Sponsor's protocol ID
- RMB 0443-13
- Other IDs
- 0443-13-RMB
- Acronym
- PXN
- Status last verified
- May 2015
- First submitted
- 29 Jan 2014
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare Fertilizations With Immotile Sperm After Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation
- ClinicalTrials.gov ID
- NCT02051075
- Acronym / sponsor ID
- PXN / RMB 0443-13
- Conditions
- Infertility
- Keywords
- IVF, ICSI, Asthenospermia, pentoxyphylline, Spermatozoa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: failure to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
Immotile sperm is a rather frequent problem encountered in IVF patients. Treatment is usually based on inducing motility with pentoxyphylline (PXN) followed by ICSI. However, fertilization rate with this method is still lower compared with ICSI using motile sperm. One of the reasons for that is the immotile sperm inability to activate the oocyte Our research hypothesis is that better fertilization rate can be accomplished in these cases by combining PXN sperm activation with Ca ionophore oocyte activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PXN only | Active comparator | Biological: PXN sperm treatmentSperm activation with PXN before ICSI |
| PXN activation and oocyte activation | Experimental | Biological: Sperm activation with PXN and oocyte activationSperm activation with PXN and oocyte activation |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women up to 35 years of age
- immotile sperm
- At least 6 mature eggs
Key exclusion criteria (2 listed)
- globozoospermia
- "Freeze all" cycles because of OHSS risk.
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 |
|---|---|---|
| PXN sperm treatmentimmotile sperm activation with PXN | Biological | PXN only |
| Sperm activation with PXN and oocyte activation | Biological | PXN activation and oocyte activation |
Primary outcome
Clinical pregnancy
Time frame: One month post oocyte retrieval
Demonstration of fetal heart activity 1 month post oocyte retrieval.
1 secondary outcome
Fertilization rate
Time frame: One day post oocyte retrieval
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PXN sperm treatment and Sperm activation with PXN and oocyte activation in people with Infertility, run by Rambam Health Care Campus at 1 site in Israel.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 6 May 2015. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy (time frame: One month post oocyte retrieval). 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 6 May 2015.