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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: MSOME

• Registration Number: NCT01731639
• Lead Sponsor: Sapientiae Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSOME	MSOME	The samples will be evaluated under high magnification

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Implantation rates	1 month	Number of gestational sacs divided by the number of transferred embryos.

Trial Locations

Locations (1)

Sapientiae Institute; 🇧🇷 São Paulo, Brazil