NCT02401997

Brief Summary

To determine the ideal sexual abstinence time for producing high quality sperm

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

March 12, 2015

Last Update Submit

August 5, 2015

Conditions

Keywords

spermoxidative stresssexual abstinence

Outcome Measures

Primary Outcomes (1)

  • Effect of sexual abstinence period on oxidative stress status of seminal plasma collected for homologous artificial insemination

    The study population is grouped according to the husbands sexual abstinence period before the time of sperm collection for homologous artificial insemination as 0-2 days vs 2-4 days vs 4-6 days

    0-2 days vs 2-4 days vs 4-6 days

Study Arms (3)

sexual abstinence period group I

ACTIVE COMPARATOR

The subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. Group I male partners have sexual abstinence period of 2 days or less.

Behavioral: sexual abstinence

sexual abstinence period group II

ACTIVE COMPARATOR

The subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. Group II male partners have sexual abstinence period of 2 to 4 days.

Behavioral: sexual abstinence

sexual abstinence period group III

ACTIVE COMPARATOR

The subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. Group II male partners have sexual abstinence period of more than 4 days

Behavioral: sexual abstinence

Interventions

The subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination.

sexual abstinence period group Isexual abstinence period group IIsexual abstinence period group III

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had made an application to Gazi University Obstetrics and Gynecology clinic for infertility and planned to have IUI (intrauterine insemination)

You may not qualify if:

  • Erectile dysfunction- improper semen collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Obstetrics and Gynecology Clinic

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sexual Abstinence

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gazi University

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 30, 2015

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations