NCT04849156

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

April 13, 2021

Last Update Submit

August 3, 2022

Conditions

Male Infertility

Keywords

Spermatozoa selectionThermotaxisTesticular and sperm biology

Outcome Measures

Primary Outcomes (1)

  • Percentage of normal spermatozoa morphology

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

    11 months

Interventions

Sperm selection by thermotaxisOTHER

Selection of healthy sperm by thermotaxis procedure

Eligibility Criteria

Age18 Years - 39 Years
Sexmale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

10 male sperm donors.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Valenciano de Infertilidade de Lisboa

Lisbon, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sperm samples

MeSH Terms

Conditions

Infertility, MaleTaxis Response

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesBehavior, AnimalBehaviorOrientation, SpatialSpatial Behavior

Study Officials

  • Kadir Guleresi, Master

    Instituto Valenciano de Infertilidade de Lisboa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 19, 2021

Study Start

April 12, 2021

Primary Completion

January 5, 2022

Study Completion

March 9, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)