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临床试验/NCT04955782
NCT04955782Unknown不适用

Abstinence Period and Semen Quality

ART Fertility Clinics LLC1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年9月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
1
主要终点
Seminal pH

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Seminal pH

时间窗: 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)

Sperm viability

时间窗: 1 day

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

Sperm motility

时间窗: 1 day

The samples motility (in % of A, B, C, D) will be analyzed in laboratory by Neubauer chamber.

Sperm count

时间窗: 1 day

Sperm count in mill/ml

Ejaculate volume

时间窗: 1 day

Ejaculate volume in ml

Sperm concentration

时间窗: 1 day

The samples concentration in mill/ml will be analyzed in laboratory by Neubauer chamber

Sperm morphology

时间窗: 1 day

Morphology (in %) will be assessed by RAL Diff-Quik kit (3x0.5L) from RAL Diagnostics, France as per the manufacturers' recommendation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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