Sperm Quality in Consecutive Sperm Samples After 4-7 Days and 2 Hours of Sexual Abstinence

January 23, 2017 updated by: Hiva Alipour, Aalborg University

Parameters of Sperm Quality in Consecutive Sperm Samples From Males Partners of Couples Seeking Treatment for Infertility

The main purpose of the study is to assess to which degree a series of sperm parameters known to be associated with fertilization and implantation potential in artificial reproductive technology (ART) differ in consecutive sperm samples produced after 2-7 days and 2 hours of sexual abstinence in males from couples referring for ART treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Dronninglund, Denmark, 9330
        • Aalborg University Hospital, Dronninglund Fertility Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male age between 18 and 50
  • able to understand and read Danish

Exclusion Criteria:

  • complete azospermia
  • significant psychological illness
  • significant cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ejaculate 1
Semen sample after 2-7 days of sexual abstinence
Other: 2-7 days of Sexual abstinence
2-7 days of Sexual abstinence
Active Comparator: Ejaculate 2
Semen sample after 2 hours of sexual abstinence
Other: 2 hours of sexual abstinence
2 hours of sexual abstinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Routine semen quality assessment
Time Frame: After liquefaction (30-35 minutes after ejaculation)
Routine sperm quality check including Morphology, Motility and DNA fragmentation index using both the conventional manual method and computer assisted sperm analysis (CASA) systems.
After liquefaction (30-35 minutes after ejaculation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of ART treatments
Time Frame: up to one year after the sampling
assessing and correlating the sperm quality with the results of the ART procedures
up to one year after the sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Collaborators

Aalborg University Hospital

Investigators

  • Study Director: Ole Bjarane M.D., Ph.D., M.D., Ph.D., Aalborg University Hospital, Gynecology Department
  • Principal Investigator: Hiva Alipour, D.V.M., Aalborg University, Faculty of Medicine, Department of Health Science and Technology
  • Study Chair: Fereshteh Dardmeh, D.V.M., Aalborg University, Faculty of Medicine, Department of Health Science and Technology
  • Study Chair: Gerhard Van DerHorst, Ph.D., University of the Western Cape, Capetown, South Africa
  • Study Chair: Christina Hnida, Ph.D., Aalborg University Hospital, Gynecology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N-20140023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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