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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01793272
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahmad Raef Sadek, Adam International Hospital
  Purpose
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.

Condition Intervention
Pentoxifylline Allergy Other: effect of pentoxifylline on ICSI outcome

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ahmad Raef Sadek, Adam International Hospital:

Primary Outcome Measures:
  • ICSI outcome [ Time Frame: from October 2010 to April 2011. ]

Enrollment: 120
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pentoxifylline
effect of pentoxifylline on ICSI outcome
Other: effect of pentoxifylline on ICSI outcome
semen processing with pentoxifylline prior to 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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793272


Locations
Egypt
Adam International Hospital
Giza, Egypt, 12411
Sponsors and Collaborators
Adam International Hospital
Investigators
Study Director: Medhat Amer, MD M.Amer
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ahmad Raef Sadek, Ahmad Raef, Adam International Hospital
ClinicalTrials.gov Identifier: NCT01793272     History of Changes
Other Study ID Numbers: 11-2-13
First Submitted: February 14, 2013
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants