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Search / Trial NCT01727947

Influence of Sperm With Large Nuclear Vacuole on ICSI Outcomes

Launched by SAPIENTIAE INSTITUTE · Nov 12, 2012

Trial Information

Current as of June 21, 2025

Completed

Keywords

ClinConnect Summary

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 ma...

Gender

ALL

Eligibility criteria

  • 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

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

Sao Paulo, Sp, 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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