Spermatozoa Morphology Selection by Thermotaxis

Male Infertility Clinical Trial

Official title:

Sperm Selection by Thermotaxis: a Novel Technique to Enhance Assisted Reproductive Technologies' Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849156
• Other study ID #: 1902-LIS-028-SR
• Status: Completed
• Start date: April 12, 2021
• Est. completion date: March 9, 2022

Study information

• Verified date: August 2022
• Source: Instituto Valenciano de Infertilidade de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to eventually assess the usefulness of thermotaxis for sperm selection in routine clinical practice.

Description:

As the world's total fertility rate decline, every year more couples require assisted reproductive technologies (ART) in order to achieve their desire to become parents. However, these techniques are not guaranteed solutions and still many couples with unexplained infertility fail to conceive. One of the reasons might be the relative selection of spermatozoa for the following ART. To minimize a poor selection made by the operator and to standardize spermatozoa selection, we suggest a new method might be used in combination with the routine spermatozoa selection techniques. Thermotaxis might be used in the ART setting as a tool to select the best spermatozoa as human spermatozoa after capacitation responds positively to a temperature gradient change. Moreover, this might be the possible navigation mechanism of spermatozoa in the female genital tract. We hypothesize that spermatozoa selected by thermotaxis behavior might increase the morphologically normal spermatozoa number in the cohort used during ART. The aim of this study is to evaluate if thermotaxis is a good method for selecting morphologically normal sperm for ART.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 9, 2022
• Est. primary completion date: January 5, 2022
• Gender: Male
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Age: =18 and <40 years old.
• Spermatozoa concentration >15 x 106 /mL in all sperm analysis performed in the last 24 months.
• Spermatozoa mobility >32% in all sperm analysis performed in the last 24 months.
• Spermatozoa morphology >4% in all sperm analysis performed in the last 24 months.
• Signed and dated informed consent

Exclusion Criteria:

• Use of antibiotics, intravenous illicit drugs, chemotherapy or radiotherapy usage in the last 3 months.
• Active smoking (during the preceding 12 months).
• More than 3 days prior to the last ejaculation.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Other:
• Sperm selection by thermotaxis
Selection of healthy sperm by thermotaxis procedure

Locations

Country	Name	City	State
Portugal	Instituto Valenciano de Infertilidade de Lisboa	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidade de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of normal spermatozoa morphology	Analysis of sperm samples following thermotaxis (intervention) versus the controls (without thermotaxis).	11 months