Abstinence Period and Semen Quality

Sponsor

ART Fertility Clinics LLC (Other)

Overall Status

Recruiting

CT.gov ID

NCT04955782

Collaborator

(none)

250

Enrollment

Location

11.5

Anticipated Duration (Months)

21.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male	Behavioral: samples will be analyzed for semen volume, pH, count, concentration, motility, morphology and viability

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Abstinence Period and Semen Quality

Actual Study Start Date :

Sep 16, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Seminal pH [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)
Ejaculate volume [1 day]
Ejaculate volume in ml
Sperm viability [1 day]
Vitality (in%) will be analyzed by Vital screen, FertiPro N.V. Belgium,as per guidelines of manufacturer.
Sperm motility [1 day]
The samples motility (in % of A, B, C, D) will be analyzed in laboratory by Neubauer chamber.
Sperm count [1 day]
Sperm count in mill/ml
Sperm concentration [1 day]
The samples concentration in mill/ml will be analyzed in laboratory by Neubauer chamber
Sperm morphology [1 day]
Morphology (in %) will be assessed by RAL Diff-Quik kit (3x0.5L) from RAL Diagnostics, France as per the manufacturers' recommendation

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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).