Motile Sperm Organelle Morphology Examination (MSOME) Influence on Intracytoplasmic Sperm Injection (ICSI) Outcomes in Infertile Couples

Pregnancy Clinical Trial

Official title:

The Influence of Motile Sperm Organelle Morphology Examination on ICSI Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731639
• Other study ID #: MSOME_Grades
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: November 17, 2014
• Start date: January 2013
• Est. completion date: December 2013

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

A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing intracytoplasmic sperm injection (ICSI) outcomes.

Description:

Sperm morphology has been described as one of the major determinants of male in vitro fertility. However, the standard morphology evaluation on random stained cells from the ejaculate is of limited value during ICSI. Current research is directed towards the dysmorphisms of the sperm head.A new technique based on the motile sperm organelle morphology examination (MSOME) at a magnification of at least ×6000 has been developed. The MSOME assesses the nucleus, for both shape and chromatin content, which is the most important sperm organelle in influencing ICSI outcomes. The goals for this study are to identify whether there is a connection between morphologic sperm normalcy under high magnification and (i) semen analysis according to the new World Health Organization (WHO) reference values and (ii) ICSI outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Couples undergoing 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
The semen samples will be evaluated according to the 2010 WHO reference values. After ICSI 200 spermatozoa of each sample will be analyzed under high magnification (MSOME - x6600) and graded into four groups according to the presence or size of the vacuoles. Grade I: normal form and no vacuoles; grade II: normal form and = 2 small vacuoles; grade III: normal form > 2 small vacuoles or at least one large vacuole and grade IV: large vacuole and abnormal head shapes or other abnormalities.

Locations

Country	Name	City	State
Brazil	Sapientiae Institute	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sapientiae Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rates	Number of clinical pregnancy rate divided by the number of couples in which embryo transfer was performed.	1 month	No
Secondary	Implantation rates	Number of gestational sacs divided by the number of transferred embryos.	1 month	No