Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: MSOME

• Registration Number: NCT01727947
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-12
• Study First Posted: 2012-11-16
• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSOME	MSOME	Couples in which the sperm cells were analysed through MSOME

Primary Outcome Measures

Name	Time	Method
Pregnancy	1 month	Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed

Trial Locations

Locations (1)

Sapientiae Institute; 🇧🇷 Sao Paulo, SP, Brazil