NCT01793272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

February 14, 2013

Last Update Submit

February 14, 2013

Conditions

Pentoxifylline Allergy

Outcome Measures

Primary Outcomes (1)

  • ICSI outcome

    from October 2010 to April 2011.

Study Arms (1)

Pentoxifylline

OTHER

effect of pentoxifylline on ICSI outcome

Other: effect of pentoxifylline on ICSI outcome

Interventions

effect of pentoxifylline on ICSI outcomeOTHER

semen processing with pentoxifylline prior to ICSI

Pentoxifylline

Eligibility Criteria

AgeUp to 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • seeking ICSI for infertility

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adam International Hospital

Giza, Giza Governorate, 12411, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 24639720DERIVED

Study Officials

  • Medhat Amer, MD

    M.Amer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ahmad Raef

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 15, 2013

Study Start

October 1, 2010

Primary Completion

April 1, 2011

Study Completion

October 1, 2011

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

EG(1)