Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes

Influence of Sperm With Large Nuclear Vacuoles on the Cycles' Outcomes of Couples Couples Undergoing ICSI

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: MSOME

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
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04503-040
      • Sapientiae Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed	1 month

Collaborators and Investigators

• Sponsor: Sapientiae Institute
• Investigators: Principal Investigator: Edson Borges Jr., MD., PhD, Sapientiae Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 12, 2012
• First Submitted That Met QC Criteria: November 12, 2012
• First Posted (Estimate): November 16, 2012

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: MSOME_SLV