Sperm Morphology by High Magnification in Fertility Men (FERTIFORT)

July 4, 2013 updated by: University Hospital, Toulouse

Assessment of Sperm Morphology by High Magnification (x6000) With Interference Contrast Microscopy in Fertile Men.

A new concept for observing the fine morphology of spermatozoa at high magnification (x6000) with an inverted microscope, a numeric camera using differential interference contrast has been developed (1). This technique called Motile Sperm Organellar Morphology Examination allows to see some abnormalities, mainly vacuoles on the head of spermatozoa. These vacuoles appear to be related to sperm DNA damage and to affect embryo developmental potential (2, 3, 4). The application of Motile Sperm Organellar Morphology Examination may represent an improvement in the evaluation of semen quality, with some potential clinical repercussions at the diagnostic/prognostic level. First of all, the investigators need data on fertile men in order to define " normality " of sperm morphology at high magnification. The aim of this study is therefore to better characterize these vacuoles (number, surface, position) in a population of men fertile in order to establish normality criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The population studied consisted in 50 men aged 18 to 45 years with proven spontaneous fertility. All subjects gave their informed consent to participate in the study. After questioning on full medical and andrological history, semen samples were collected by masturbation after 2 to 5 days of sexual abstinence and were processed for analysis after liquefaction for 20 min at 37°C. We carried out a sperm count, motility, vitality and conventional morphology analysis as well as a detailed morphometric analysis of the vacuoles at high magnification using an image analysis software. For the analysis at high magnification, fifty microliters of fresh sperm was washed in 2.5 ml of washing solution by centrifugation for 5 minutes at 400g. The pellet was resuspended in 100 µl of washing solution and the spermatozoa were fixed by addition of 100 µl Phosphate Buffer Saline-formaldehyde 3.7%. Two microliters of this suspension was placed in a glass-bottomed dish and examined by Nomarski interference contrast microscopy with a camera mounted on a microscope with an immersion objective lens x100. For each sample, sperm head vacuoles were analyzed on 100 spermatozoa that were randomly photographed and separately analyzed using digital imaging system software. Measurements using the software were carried out by a single operator. The Interactive Measurement module allows measurement of sperm head areas and vacuole areas by manually depicting their outline. The area and position of each vacuole were recorded.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Centre d'AMP Hôpital Paule de Viguier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

INCLUSION CRITERIA:

  • Age : between 18 and 45 years
  • Sex : male
  • Men with proven spontaneous fertility (the pregnancy started less than two years before inclusion)
  • 2 to 5 days of sexual abstinence
  • All subjects gave their informed consent to participate in the study
  • The subjects must be affiliated to a social security scheme.

EXCLUSION CRITERIA:

  • Personal history of infertility
  • Personal history of chemotherapy
  • History of recurrent miscarriage in the couple
  • Andrological history since the last pregnancy: urogenital infection, testicular trauma, testicular torsion, varicocele, abdominopelvic surgery
  • Fever within 3 months before inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fertile men
Assessment of sperm morphology by high magnification with interference contrast microscopy.
Other: Assessment of sperm morphology (contrast microscopy).
Sperm head vacuoles were analyzed on 100 spermatozoa that were randomly photographed and separately analyzed using digital imaging system software. Interactive Measurement module allows measurement of sperm head areas and vacuole areas by manually depicting their outline. The area and position of each vacuole were recorded. Relative vacuole area is the ratio of the area of all the vacuoles of a spermatozoon to the area of its head.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of vacuole and mean vacuolar area
Time Frame: 1 day
For each patient, images of 100 spermatozoa was captured the day of the sperm collection
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome measure: Vacuole localization, Semen volume, sperm count, motility, vitality, percentage of normal forms.
Time Frame: 1 day
For each patient, the secondary outcome measures were collected the day of the inclusion.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Roger LEANDRI, MD-PhD, University Hospital of Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

July 4, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 4, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11 175 03
  • HAO 2011 (Other Grant/Funding Number: ARTS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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