Study Stopped
failure to recruit
Fertilizations With Immotile Sperm: Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation
PXN
A Randomized Controlled Trial to Compare Fertilizations With Immotile Sperm After Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation
2 other identifiers
interventional
N/A
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
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Started Mar 2014
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 6, 2015
May 1, 2015
1.2 years
January 29, 2014
May 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy
Demonstration of fetal heart activity 1 month post oocyte retrieval.
One month post oocyte retrieval
Secondary Outcomes (1)
Fertilization rate
One day post oocyte retrieval
Study Arms (2)
PXN only
ACTIVE COMPARATORSperm activation with PXN before ICSI
PXN activation and oocyte activation
EXPERIMENTALSperm activation with PXN and oocyte activation
Interventions
Eligibility Criteria
You may qualify if:
- Women up to 35 years of age
- immotile sperm
- At least 6 mature eggs
You may not qualify if:
- globozoospermia
- "Freeze all" cycles because of OHSS risk.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam medical Center
Haifa, Israel, 31096, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Durector, IVF Unit
Study Record Dates
First Submitted
January 29, 2014
First Posted
January 31, 2014
Study Start
March 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 6, 2015
Record last verified: 2015-05