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Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sapientiae Institute
ClinicalTrials.gov Identifier:
NCT01727947
First received: November 12, 2012
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Sapientiae Institute:

Primary Outcome Measures:
  • Pregnancy [ 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


Enrollment: 200
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727947

Locations
Brazil
Sapientiae Institute
Sao Paulo, SP, Brazil, 04503-040
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: NCT01727947     History of Changes
Other Study ID Numbers: MSOME_SLV
Study First Received: November 12, 2012
Last Updated: November 17, 2014
Health Authority: Brazil: Ethics Committee

ClinicalTrials.gov processed this record on November 20, 2014