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Completed

NCT Number: NCT01731639

Motile Sperm Organelle Morphology Examination (MSOME) Influence on Intracytoplasmic Sperm Injection (ICSI) Outcomes in Infertile Couples

A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing intracytoplasmic sperm injection (ICSI) outcomes.

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Key information

Conditions

Pregnancy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapientiae Institute

São Paulo, 04503-040, Brazil

About this study

Sperm morphology has been described as one of the major determinants of male in vitro fertility. However, the standard morphology evaluation on random stained cells from the ejaculate is of limited value during ICSI. Current research is directed towards the dysmorphisms of the sperm head.A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing ICSI outcomes. The goals for this study are to identify whether there is a connection between morphologic sperm normalcy under high magnification and (i) semen analysis according to the new World Health Organization (WHO) reference values and (ii) ICSI outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Couples undergoing ICSI as result of male factor or tubal factor or unexplained infertility
  • Women with regular menstrual cycles of 25-35 days
  • Women with normal basal follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels
  • Women with body mass index (BMI) less than 30 kg/m2
  • Women with both ovaries and intact uterus

Exclusion criteria

  • Women with polycystic ovaries syndrome
  • Women with endometriosis
  • Women with gynaecological/medical disorders
  • Couples with any sexually transmitted disease
  • Women who had received any hormone therapy for less than 60 days preceding the study

Treatment and study plan

MSOME

Other

The semen samples will be evaluated according to the 2010 WHO reference values. After ICSI 200 spermatozoa of each sample will be analyzed under high magnification (MSOME - x6600) and graded into four groups according to the presence or size of the vacuoles. Grade I: normal form and no vacuoles; grade II: normal form and ≤ 2 small vacuoles; grade III: normal form > 2 small vacuoles or at least one large vacuole and grade IV: large vacuole and abnormal head shapes or other abnormalities.

Primary outcomes

  1. Pregnancy rates

    Time frame: 1 month

    Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed.

Secondary outcomes

  1. Implantation rates

    Time frame: 1 month

    Number of gestational sacs divided by the number of transferred embryos.

Sponsors and collaborators

Lead sponsor

Sapientiae Institute

Other

Registry information

Official study title

The Influence of Motile Sperm Organelle Morphology Examination on ICSI Outcomes

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2012
Registry last updated
Nov 18, 2014

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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