Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727947
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : November 18, 2014
Information provided by (Responsible Party):
Sapientiae Institute

Brief Summary:
Current research on sperm morphology has been directed towards the dysmorphisms of the sperm head. A new technique based on the motile sperm organelle morphology examination (MSOME) allows the detection of sperm with large nuclear vacuoles (SLV). Large nuclear vacuoles are specific sperm alterations observed under high magnification, and their presence has been related to increased DNA fragmentation and denaturation.

Condition or disease Intervention/treatment Phase
Pregnancy Other: MSOME Not Applicable

Detailed Description:
A new method for the detailed morphological evaluation of motile spermatozoa in real time, under high magnification, named "motile sperm organellar morphology examination" (MSOME) was developed. This magnification provides an accurate description of spermatozoa abnormalities, particularly the presence of head vacuoles, which is indicative of abnormal chromatin packaging in spermatozoa. However, the influence of sperm with large nuclear vacuoles (SLV) on ART outcomes is still a matter of debate. The goals for this study were to identify whether there is a connection between SLV under high magnification and ICSI outcomes.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Influence of Sperm With Large Nuclear Vacuoles on the Cycles' Outcomes of Couples Couples Undergoing ICSI
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: MSOME
Couples in which the sperm cells were analysed through MSOME
Other: MSOME
A total of 200 spermatozoa of each sample will be analyzed under high magnification (x6600) and the incidence of SLV (sperm cells presenting at least one vacuole that occupied > 13% of nuclear area) in each sample will be assessed.

Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 1 month ]
    Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Couples undergoing intracytoplasmic sperm injection (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01727947

Sapientiae Institute
Sao Paulo, SP, Brazil, 04503-040
Sponsors and Collaborators
Sapientiae Institute
Principal Investigator: Edson Borges Jr., MD., PhD Sapientiae Institute

Responsible Party: Sapientiae Institute Identifier: NCT01727947     History of Changes
Other Study ID Numbers: MSOME_SLV
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014