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

NCT ID: NCT02051075

Last Updated: 2015-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PXN only

Sperm activation with PXN before ICSI

Group Type ACTIVE_COMPARATOR

PXN sperm treatment

Intervention Type BIOLOGICAL

immotile sperm activation with PXN

PXN activation and oocyte activation

Sperm activation with PXN and oocyte activation

Group Type EXPERIMENTAL

Sperm activation with PXN and oocyte activation

Intervention Type BIOLOGICAL

Interventions

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PXN sperm treatment

immotile sperm activation with PXN

Intervention Type BIOLOGICAL

Sperm activation with PXN and oocyte activation

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Shahar Kol MD

Durector, IVF Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rambam medical Center

Haifa, Israel, Israel

Site Status

Countries

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Israel

Other Identifiers

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0443-13-RMB

Identifier Type: OTHER

Identifier Source: secondary_id

RMB 0443-13

Identifier Type: -

Identifier Source: org_study_id

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