An observational study in Infertility, Male, sponsored by ART Fertility Clinics LLC. Status unknown at 1 site in Oman. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by ART Fertility Clinics LLC · Observational
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
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.
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This study's planned enrollment of 250 is above the median of 200 across 714 observational studies indexed under Infertility.
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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.
Exclusion Criteria:
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
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
Seminal pH
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)
Time frame: 1 day
Ejaculate volume
Ejaculate volume in ml
Time frame: 1 day
Sperm viability
Vitality (in%) will be analyzed by Vital screen, FertiPro N.V. Belgium,as per guidelines of manufacturer.
Time frame: 1 day
Sperm motility
The samples motility (in % of A, B, C, D) will be analyzed in laboratory by Neubauer chamber.
Time frame: 1 day
Sperm count
Sperm count in mill/ml
Time frame: 1 day
Sperm concentration
The samples concentration in mill/ml will be analyzed in laboratory by Neubauer chamber
Time frame: 1 day
Sperm morphology
Morphology (in %) will be assessed by RAL Diff-Quik kit (3x0.5L) from RAL Diagnostics, France as per the manufacturers' recommendation
Time frame: 1 day
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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