- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02401997
The Effect of the Sexual Abstinence Period on the Production of Reactive Oxygen Species in Patients Who Planned to Take Part in Intrauterine Insemination
August 5, 2015 updated by: Prof Ahmet ERDEM, MD, Gazi University
To determine the ideal sexual abstinence time for producing high quality sperm
Study Overview
Study Type
Interventional
Enrollment (Actual)
90
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
-
-
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Ankara, Turkey
- Gazi University Obstetrics and Gynecology Clinic
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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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Patients who had made an application to Gazi University Obstetrics and Gynecology clinic for infertility and planned to have IUI (intrauterine insemination)
Exclusion Criteria:
- Erectile dysfunction- improper semen collection
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: sexual abstinence period group I
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.
|
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.
|
Active Comparator: sexual abstinence period group II
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.
|
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.
|
Active Comparator: sexual abstinence period group III
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of sexual abstinence period on oxidative stress status of seminal plasma collected for homologous artificial insemination
Time Frame: 0-2 days vs 2-4 days vs 4-6 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
March 12, 2015
First Submitted That Met QC Criteria
March 27, 2015
First Posted (Estimate)
March 30, 2015
Study Record Updates
Last Update Posted (Estimate)
August 6, 2015
Last Update Submitted That Met QC Criteria
August 5, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 01/2011-110
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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