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Search / Trial NCT01731639

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

Launched by SAPIENTIAE INSTITUTE · Nov 21, 2012

Trial Information

Current as of July 23, 2025

Completed

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

  • 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

About Sapientiae Institute

The Sapientiae Institute is a leading clinical trial sponsor dedicated to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a strong emphasis on ethical standards and scientific rigor, the Institute collaborates with academic institutions, healthcare providers, and industry partners to design and conduct clinical trials across various therapeutic areas. Committed to transparency and integrity, the Sapientiae Institute aims to facilitate the efficient development of safe and effective treatments, contributing to the overall enhancement of global health.

Locations

São Paulo, , Brazil

São Paulo, , Brazil

Patients applied

0 patients applied

Trial Officials

Edson Borges Jr., MD., PhD

Principal Investigator

Sapientiae Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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