NCT01895192

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

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, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

January 22, 2013

Last Update Submit

July 4, 2013

Conditions

MenFertility

Keywords

sperm morphologyvacuolesfertileMotile Sperm Organellar Morphology Examinationhigh magnificationreference values

Outcome Measures

Primary Outcomes (1)

  • Mean number of vacuole and mean vacuolar area

    For each patient, images of 100 spermatozoa was captured the day of the sperm collection

    1 day

Secondary Outcomes (1)

  • Composite outcome measure: Vacuole localization, Semen volume, sperm count, motility, vitality, percentage of normal forms.

    1 day

Study Arms (1)

Fertile men

OTHER

Assessment of sperm morphology by high magnification with interference contrast microscopy.

Other: Assessment of sperm morphology (contrast microscopy).

Interventions

Assessment of sperm morphology (contrast microscopy).OTHER

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.

Fertile men

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age : between 18 and 45 years
  • Sex : male
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'AMP Hôpital Paule de Viguier

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Roger LEANDRI, MD-PhD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

July 10, 2013

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

February 1, 2013

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

FR(1)