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Beneficial Effect of Adding Pentoxifylline to Processed Semen Samples on ICSI Outcome in Infertile Males

Primary Purpose

Pentoxifylline Allergy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
effect of pentoxifylline on ICSI outcome
Sponsored by
Adam International Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pentoxifylline Allergy

Eligibility Criteria

undefined - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • seeking ICSI for infertility

Exclusion Criteria:

  • Pyospermia, presence of antisperm antibodies. Azoospermia, severe male factor, severe asthenozoospermia. Past history of orchitis. Patients who received empirical treatment for asthenozoospermia e.g. oral Pentoxifylline, l-carnitine or antioxidants during the past 3 to 6 month. Diabetics, hypertensives or patients with any other chronic systemic illnesses. Wife's age more than 35 years. Low antral count. Presence of any ovarian factor contributing to infertility e.g. polycystic ovaries.

Sites / Locations

  • Adam International Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pentoxifylline

Arm Description

effect of pentoxifylline on ICSI outcome

Outcomes

Primary Outcome Measures

ICSI outcome

Secondary Outcome Measures

Full Information

First Posted
February 14, 2013
Last Updated
February 14, 2013
Sponsor
Adam International Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01793272
Brief Title
Beneficial Effect of Adding Pentoxifylline to Processed Semen Samples on ICSI Outcome in Infertile Males
Official Title
Beneficial Effect of Adding Pentoxifylline to Processed Semen Samples on ICSI Outcome in Infertile Males With Mild and Moderate Asthenozoospermia: Randomized Controlled Prospective Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adam International Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the effect of pentoxifylline used in preparation of semen samples that will be used for ICSI in infertile men complaining of mild and moderate asthenozoospermia (i.e. cases which does not need motility enhancement prior to ICSI) in comparison to semen samples without pentoxifylline preparation on the outcome of ICSI.
Detailed Description
The primary outcome measures were the number of oocytes retrieved, the number of oocytes injected, number of oocytes fertilized, fertilization rate, number of embryos and their quality (G1: good embryos, G2: fair embryos and G3: bad embryos), number of embryos transferred (ET), number of embryo sacs, embryo implantation rate, pregnancy rate and abortion rate for all 3 groups and pregnancy rate and abortion rate for both group (I) and group (II).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pentoxifylline Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pentoxifylline
Arm Type
Other
Arm Description
effect of pentoxifylline on ICSI outcome
Intervention Type
Other
Intervention Name(s)
effect of pentoxifylline on ICSI outcome
Intervention Description
semen processing with pentoxifylline prior to ICSI
Primary Outcome Measure Information:
Title
ICSI outcome
Time Frame
from October 2010 to April 2011.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: seeking ICSI for infertility Exclusion Criteria: Pyospermia, presence of antisperm antibodies. Azoospermia, severe male factor, severe asthenozoospermia. Past history of orchitis. Patients who received empirical treatment for asthenozoospermia e.g. oral Pentoxifylline, l-carnitine or antioxidants during the past 3 to 6 month. Diabetics, hypertensives or patients with any other chronic systemic illnesses. Wife's age more than 35 years. Low antral count. Presence of any ovarian factor contributing to infertility e.g. polycystic ovaries.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medhat Amer, MD
Organizational Affiliation
M.Amer
Official's Role
Study Director
Facility Information:
Facility Name
Adam International Hospital
City
Giza
ZIP/Postal Code
12411
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
24639720
Citation
Amer M, Metawae B, Hosny H, Raef A. Beneficial effect of adding pentoxifylline to processed semen samples on ICSI outcome in infertile males with mild and moderate asthenozoospermia: A randomized controlled prospective crossover study. Iran J Reprod Med. 2013 Nov;11(11):939-44.
Results Reference
derived

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Beneficial Effect of Adding Pentoxifylline to Processed Semen Samples on ICSI Outcome in Infertile Males

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