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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2011

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).

Interventions

  • Other: effect of pentoxifylline on ICSI outcome
    • semen processing with pentoxifylline prior to ICSI

Arms, Groups and Cohorts

  • Other: Pentoxifylline
    • effect of pentoxifylline on ICSI outcome

Clinical Trial Outcome Measures

Primary Measures

  • ICSI outcome
    • Time Frame: from October 2010 to April 2011.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Adam International Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmad Raef Sadek, Ahmad Raef – Adam International Hospital
  • Overall Official(s)
    • Medhat Amer, MD, Study Director, M.Amer

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