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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sao Paulo, Sp, Brazil
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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