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

Sapientiae Institute

Status: Completed

Conditions: Pregnancy

Treatments: Other: MSOME

Study type: Interventional

Funder types: Other

Identifiers

NCT01731639

MSOME_Grades

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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72 participants in 1 patient group

MSOME

Experimental group

Description:

The samples will be evaluated under high magnification

Treatment:

Other: MSOME