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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ahmad Raef Sadek, Adam International Hospital
ClinicalTrials.gov Identifier:
NCT01793272
First received: February 14, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Adam International Hospital:

Primary Outcome Measures:
  • ICSI outcome [ Time Frame: from October 2010 to April 2011. ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ahmad Raef Sadek, Ahmad Raef, Adam International Hospital
ClinicalTrials.gov Identifier: NCT01793272     History of Changes
Other Study ID Numbers: 11-2-13
Study First Received: February 14, 2013
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 16, 2014