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

May 5, 2015 updated by: Shahar Kol MD, Rambam Health Care Campus

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PXN only
Sperm activation with PXN before ICSI
Biological: PXN sperm treatment
immotile sperm activation with PXN
Experimental: PXN activation and oocyte activation
Sperm activation with PXN and oocyte activation
Biological: Sperm activation with PXN and oocyte activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy
Time Frame: One month post oocyte retrieval
Demonstration of fetal heart activity 1 month post oocyte retrieval.
One month post oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: One day post oocyte retrieval
Normal, 2 pronuclei, zygote one day post ICSI
One day post oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMB 0443-13
  • 0443-13-RMB (Other Identifier: Rambam Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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