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Fertilizations With Immotile Sperm: Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation (PXN)

Primary Purpose

Infertility

Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
PXN sperm treatment
Sperm activation with PXN and oocyte activation
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF, ICSI, Asthenospermia, pentoxyphylline, Spermatozoa

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Women up to 35 years of age
  • immotile sperm
  • At least 6 mature eggs

Exclusion Criteria:

  • globozoospermia
  • "Freeze all" cycles because of OHSS risk.

Sites / Locations

  • Rambam medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PXN only

PXN activation and oocyte activation

Arm Description

Sperm activation with PXN before ICSI

Sperm activation with PXN and oocyte activation

Outcomes

Primary Outcome Measures

Clinical pregnancy
Demonstration of fetal heart activity 1 month post oocyte retrieval.

Secondary Outcome Measures

Fertilization rate
Normal, 2 pronuclei, zygote one day post ICSI

Full Information

First Posted
January 29, 2014
Last Updated
May 5, 2015
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02051075
Brief Title
Fertilizations With Immotile Sperm: Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation
Acronym
PXN
Official Title
A Randomized Controlled Trial to Compare Fertilizations With Immotile Sperm After Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
failure to recruit
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, ICSI, Asthenospermia, pentoxyphylline, Spermatozoa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PXN only
Arm Type
Active Comparator
Arm Description
Sperm activation with PXN before ICSI
Arm Title
PXN activation and oocyte activation
Arm Type
Experimental
Arm Description
Sperm activation with PXN and oocyte activation
Intervention Type
Biological
Intervention Name(s)
PXN sperm treatment
Intervention Description
immotile sperm activation with PXN
Intervention Type
Biological
Intervention Name(s)
Sperm activation with PXN and oocyte activation
Primary Outcome Measure Information:
Title
Clinical pregnancy
Description
Demonstration of fetal heart activity 1 month post oocyte retrieval.
Time Frame
One month post oocyte retrieval
Secondary Outcome Measure Information:
Title
Fertilization rate
Description
Normal, 2 pronuclei, zygote one day post ICSI
Time Frame
One day post oocyte retrieval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women up to 35 years of age immotile sperm At least 6 mature eggs Exclusion Criteria: globozoospermia "Freeze all" cycles because of OHSS risk.
Facility Information:
Facility Name
Rambam medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

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Fertilizations With Immotile Sperm: Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation

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