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

This study is currently recruiting participants.
Verified January 2013 by Sapientiae Institute
Sponsor:
Information provided by (Responsible Party):
Sapientiae Institute
ClinicalTrials.gov Identifier:
NCT01731639
First received: November 12, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Pregnancy
 Other: MSOME

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Influence of Motile Sperm Organelle Morphology Examination on ICSI Outcomes

Further study details as provided by Sapientiae Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Implantation rates [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Number of gestational sacs divided by the number of transferred embryos.


Estimated Enrollment: 72
Study Start Date: January 2013
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSOME
The samples will be evaluated under high magnification
 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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731639

Contacts
Contact: Edson B Borges Jr., MD., PhD 551130188181 edson@fertility.com.br

Locations
Brazil
Sapientiae Institute Recruiting
São Paulo, Brazil, 04503-040
Contact: Edson Borges Jr., MD., PhD     551130188181     edson@fertility.com.br    
Sponsors and Collaborators
Sapientiae Institute
Investigators
Principal Investigator: Edson Borges Jr., MD., PhD Sapientiae Institute
  More Information

No publications provided

Responsible Party: Sapientiae Institute
ClinicalTrials.gov Identifier: NCT01731639     History of Changes
Other Study ID Numbers: MSOME_Grades
Study First Received: November 12, 2012
Last Updated: January 7, 2013
Health Authority: Brazil: Ethics Committee

ClinicalTrials.gov processed this record on June 17, 2013