Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727947
• Other study ID #: MSOME_SLV
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: November 17, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: November 2014
• Source: Sapientiae Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Brazil	Sapientiae Institute	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Sapientiae Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy	Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed	1 month	No