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Completed

NCT Number: NCT01895192

Sperm Morphology by High Magnification in Fertility 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.

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Key information

Conditions

Men Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Fertility Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'AMP Hôpital Paule de Viguier

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: FERTIFORT

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 10, 2013
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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