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

NCT ID: NCT01793272

Last Updated: 2013-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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).

Conditions

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Pentoxifylline Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pentoxifylline

effect of pentoxifylline on ICSI outcome

Group Type OTHER

effect of pentoxifylline on ICSI outcome

Intervention Type OTHER

semen processing with pentoxifylline prior to ICSI

Interventions

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effect of pentoxifylline on ICSI outcome

semen processing with pentoxifylline prior to ICSI

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adam International Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Raef Sadek

Ahmad Raef

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Medhat Amer, MD

Role: STUDY_DIRECTOR

M.Amer

Locations

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Adam International Hospital

Giza, Giza Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 24639720 (View on PubMed)

Other Identifiers

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11-2-13

Identifier Type: -

Identifier Source: org_study_id

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