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Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes

NCT ID: NCT01727947

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MSOME

Couples in which the sperm cells were analysed through MSOME

Group Type EXPERIMENTAL

MSOME

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sapientiae Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edson Borges Jr., MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Sapientiae Institute

Locations

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Sapientiae Institute

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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MSOME_SLV

Identifier Type: -

Identifier Source: org_study_id