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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01727947

Enrollment

200

Registered

2012-11-16

Start date

2013-01-31

Completion date

2014-01-31

Last updated

2014-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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.

Interventions

OTHERMSOME

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026