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Completed

NCT Number: NCT04849156

Spermatozoa Morphology Selection by Thermotaxis

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

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Key information

Age range

18 year–39 year

Sex eligibility

Male

Study type

Observational

Primary location

Instituto Valenciano de Infertilidade de Lisboa

Lisbon, Portugal

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sperm selection by thermotaxis

Other

Selection of healthy sperm by thermotaxis procedure

Primary outcomes

  1. Percentage of normal spermatozoa morphology

    Time frame: 11 months

    Analysis of sperm samples following thermotaxis (intervention) versus the controls (without thermotaxis).

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidade de Lisboa

Network

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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