Spermatozoa Morphology Selection by Thermotaxis

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

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

Study Overview

• Status: Completed
• Conditions: Male Infertility
• Intervention / Treatment: Other: Sperm selection by thermotaxis

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal
    • Instituto Valenciano de Infertilidade de Lisboa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

10 male sperm donors.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of normal spermatozoa morphology	Analysis of sperm samples following thermotaxis (intervention) versus the controls (without thermotaxis).	11 months

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidade de Lisboa
• Investigators: Principal Investigator: Kadir Guleresi, Master, Instituto Valenciano de Infertilidade de Lisboa

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): January 5, 2022
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Spermatozoa selection; Thermotaxis; Testicular and sperm biology
• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: 1902-LIS-028-SR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No