NCT02667080

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

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 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

January 25, 2016

Last Update Submit

January 23, 2017

Conditions

Semen Quality

Keywords

Semen qualitySexual Abstinencesperm motilityDNA fragmentation

Outcome Measures

Primary Outcomes (1)

  • Routine semen quality assessment

    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 Outcomes (1)

  • Outcome of ART treatments

    up to one year after the sampling

Study Arms (2)

Ejaculate 1

ACTIVE COMPARATOR

Semen sample after 2-7 days of sexual abstinence

Other: 2-7 days of Sexual abstinence

Ejaculate 2

ACTIVE COMPARATOR

Semen sample after 2 hours of sexual abstinence

Other: 2 hours of sexual abstinence

Interventions

2-7 days of Sexual abstinenceOTHER

2-7 days of Sexual abstinence

Ejaculate 1
2 hours of sexual abstinenceOTHER

2 hours of sexual abstinence

Ejaculate 2

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • complete azospermia
  • significant psychological illness
  • significant cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital, Dronninglund Fertility Clinic

Dronninglund, 9330, Denmark

Location

MeSH Terms

Conditions

Sexual Abstinence

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Ole Bjarane M.D., Ph.D., M.D., Ph.D.

    Aalborg University Hospital, Gynecology Department

    STUDY DIRECTOR

  • Hiva Alipour, D.V.M.

    Aalborg University, Faculty of Medicine, Department of Health Science and Technology

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Student, Research Assistant

Study Record Dates

First Submitted

January 25, 2016

First Posted

January 28, 2016

Study Start

April 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 24, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)