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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sapientiae Institute
ClinicalTrials.gov Identifier:
NCT01731639
First received: November 12, 2012
Last updated: November 17, 2014
Last verified: November 2014

November 12, 2012
November 17, 2014
January 2013
December 2013   (final data collection date for primary outcome measure)
Pregnancy rates [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed.
Pregnancy rates [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01731639 on ClinicalTrials.gov Archive Site
Implantation rates [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Number of gestational sacs divided by the number of transferred embryos.
Implantation rates [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Motile Sperm Organelle Morphology Examination (MSOME) Influence on Intracytoplasmic Sperm Injection (ICSI) Outcomes in Infertile Couples
The Influence of Motile Sperm Organelle Morphology Examination on ICSI Outcomes

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Pregnancy
Other: MSOME
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.
Experimental: MSOME
The samples will be evaluated under high magnification
Intervention: Other: MSOME
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01731639
MSOME_Grades
No
Sapientiae Institute
Sapientiae Institute
Not Provided
Principal Investigator: Edson Borges Jr., MD., PhD Sapientiae Institute
Sapientiae Institute
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP