Abstinence Period and Semen Quality

September 16, 2021 updated by: ART Fertility Clinics LLC
Does period of abstinence impact progressive motility in oligoasthenoteratozoospermic (OATS) males? In the evaluation of male fertility, semen analysis is an important investigation. An abstinence between 2 and 7 days before a diagnostic semen analysis has been recommended by WHO (WHO 2010 guidelines), for the sake of standardization. The European Society of Human Reproduction and Embryology advises 3-4 days of abstinence before a semen analysis. The exact impact of abstinence period on sperm quality is a little complex and difficult to interpret. This study, 250 men with low sperm counts, motility and morphology will be recruited. The results will be analyzed to ascertain the impact of shorter abstinence period on semen quality

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The population will be the citizens and residents of Oman. All men included in the study will be the ones diagnosed in the last one year, with oligoasthenoteratozoospermia. There are multiple factors that affect the semen parameters in assisted reproductive procedures. One of the factors is period of abstinence. It has been observed that prolonged abstinence improves semen volume and sperm concentration, but it may have a negative impact on sperm viability and motility. The present abstinence guidelines are for testing and analysis only, however, it is possible that varying periods of abstinence may lead to higher clinical pregnancies.

If sufficient sample has not been accomplished even after considering non-response, investigators will optimize sampled data with complete information required for research. Regression imputation statistical technique will be done. Instead of deleting any case that has any missing value, this approach preserves all cases by replacing the missing data with a probable value estimated by remaining information. The existing variables are used to make a prediction, and then the predicted value is substituted as if an actual obtained value. After all missing values will be replaced, the complete data set will be analyzed using the above mentioned standard techniques to meet the objectives.

The data collected will be stored in a password coded excel sheet. The verification of sample provider will be done by two people. Also, two embryologists will cross check the identifier details with the sample. The anonymity of patient will be maintained by logging the data onto an excel sheet without any name, only patient number. The sample will be identified based on the Vrepro number which is a unique ID for the patient. Eg. For patient X,ID is 0004797. The details will be saved in a sheet with the ID number 4797 only.

The data base will be rigorously defined with the variables destined to be analyzed according to the objectives set. The necessary information will be exported from the clinical information manager, Vrepro, to a table in Excel format. The exported data will be duly codified in order to protect the clinical and personal information of the patients according to the applicable law in the place where the research project is carried out. Finally and prior to the statistical study, an exploratory data analysis will be carried out to review the quality of the information extracted.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The population will be the citizens and residents of Oman. Oman is a diverse country with Omanis, Asians, Caucasians, Persians, other Arabs (eg. Egyptian, Syrian, Iraqi, Lebanese, Jordanian, Sudani) residing here. All men with oligoasthenoteratozoospermia.

Description

Inclusion Criteria:

  • A semen analysis report not more than 1 year old with sperm concentration less than or equal to 5 mill/ml and more than or equal to 0.1 mill/ml.
  • Sperm motility less than or equal to 20%.
  • Sperm morphology less than 4% normal sperms.

Exclusion Criteria:

  • Azoospermia
  • Sperm obtained from surgical sperm retrieval
  • Cryptozoospermia and Necrozoospermia
  • History of chemotherapy, radiotherapy, cryptorchidism, chronic diabetes, active smokers (someone who smokes any tobacco product at least once a day as per WHO definition).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
62-84 hours of abstinence
samples will be analyzed for semen volume, pH, count, concentration, motility, morphology and viability
Behavioral: samples will be analyzed for semen volume, pH, count, concentration, motility, morphology and viability

The volume will be measured by weighing the sample in the container in which it has been collected, it will be a pre-weighed container. The volume will be assessed by aspirating the sample using a non-toxic pre scaled surgical pipette.

The samples will be liquified in an incubator at 37 C. Complete ejaculate liquefaction is normally achieved within 15-30 minutes at room temperature (WHO2010).

pH will be analyzed 30 minutes after collection. pH test strips in range of 6.0-10.0 will be used. A value under 7.0 will indicate lack of alkaline seminal vesicular fluid (pH-Fix 0-14 from Macherey-Nagell,Germany).

The samples concentration and motility will be analyzed in laboratory by Neubauer chamber, morphology will be assessed by RAL Diff-Quik kit (3x0.5L) from RAL Diagnostics, France as per the manufacturers' recommendation.

Vitality will be analyzed by Vital screen, FertiPro N.V. Belgium,as per guidelines of manufacturer
1-3 hours of abstinence
samples will be analyzed for semen volume, pH, count, concentration, motility, morphology and viability
Behavioral: samples will be analyzed for semen volume, pH, count, concentration, motility, morphology and viability

The volume will be measured by weighing the sample in the container in which it has been collected, it will be a pre-weighed container. The volume will be assessed by aspirating the sample using a non-toxic pre scaled surgical pipette.

The samples will be liquified in an incubator at 37 C. Complete ejaculate liquefaction is normally achieved within 15-30 minutes at room temperature (WHO2010).

pH will be analyzed 30 minutes after collection. pH test strips in range of 6.0-10.0 will be used. A value under 7.0 will indicate lack of alkaline seminal vesicular fluid (pH-Fix 0-14 from Macherey-Nagell,Germany).

The samples concentration and motility will be analyzed in laboratory by Neubauer chamber, morphology will be assessed by RAL Diff-Quik kit (3x0.5L) from RAL Diagnostics, France as per the manufacturers' recommendation.

Vitality will be analyzed by Vital screen, FertiPro N.V. Belgium,as per guidelines of manufacturer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seminal pH
Time Frame: 1 day

pH will be analyzed 30 minutes after collection. pH test strips in range of 6.0-10.0 will be used.

A value under 7.0 will indicate lack of alkaline seminal vesicular fluid (pH-Fix 0-14 from Macherey-Nagell,Germany)
1 day
Ejaculate volume
Time Frame: 1 day
Ejaculate volume in ml
1 day
Sperm viability
Time Frame: 1 day
Vitality (in%) will be analyzed by Vital screen, FertiPro N.V. Belgium,as per guidelines of manufacturer.
1 day
Sperm motility
Time Frame: 1 day
The samples motility (in % of A, B, C, D) will be analyzed in laboratory by Neubauer chamber.
1 day
Sperm count
Time Frame: 1 day
Sperm count in mill/ml
1 day
Sperm concentration
Time Frame: 1 day
The samples concentration in mill/ml will be analyzed in laboratory by Neubauer chamber
1 day
Sperm morphology
Time Frame: 1 day
Morphology (in %) will be assessed by RAL Diff-Quik kit (3x0.5L) from RAL Diagnostics, France as per the manufacturers' recommendation
1 day

Collaborators and Investigators

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

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Upma Pathak Shanker, Specialist, ART Fertility Clinics LLC

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.

General Publications

Helpful Links

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 (Actual)

September 16, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2104-MUS-006-US

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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