Clinical trial NCT04955782: Abstinence Period and Semen Quality
Official title: Abstinence Period and Semen Quality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Male
Keywords: infertilty
semen analysis
semen parameters
progressive motility
abstinence period
sperm count
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 250
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Seminal pH
timeFrame: 1 day
measure: Ejaculate volume
timeFrame: 1 day
measure: Sperm viability
timeFrame: 1 day
measure: Sperm motility
timeFrame: 1 day
measure: Sperm count
timeFrame: 1 day
measure: Sperm concentration
timeFrame: 1 day
measure: Sperm morphology
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: ART Fertility Clinics LLC
Study officials:
affiliation: ART Fertility Clinics LLC
name: Upma Pathak Shanker, Specialist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjorndahl L, Barratt CL, Fraser LR, Kvist U, Mortimer D. ESHRE basic semen analysis courses 1995-1999: immediate beneficial effects of standardized training. Hum Reprod. 2002 May;17(5):1299-305. doi: 10.1093/humrep/17.5.1299.
citation: De Jonge C, LaFromboise M, Bosmans E, Ombelet W, Cox A, Nijs M. Influence of the abstinence period on human sperm quality. Fertil Steril. 2004 Jul;82(1):57-65. doi: 10.1016/j.fertnstert.2004.03.014.
citation: Agarwal A, Gupta S, Du Plessis S, Sharma R, Esteves SC, Cirenza C, Eliwa J, Al-Najjar W, Kumaresan D, Haroun N, Philby S, Sabanegh E. Abstinence Time and Its Impact on Basic and Advanced Semen Parameters. Urology. 2016 Aug;94:102-10. doi: 10.1016/j.urology.2016.03.059. Epub 2016 May 16.
citation: Borges E Jr, Braga DPAF, Zanetti BF, Iaconelli A Jr, Setti AS. Revisiting the impact of ejaculatory abstinence on semen quality and intracytoplasmic sperm injection outcomes. Andrology. 2019 Mar;7(2):213-219. doi: 10.1111/andr.12572. Epub 2018 Dec 20.
citation: Sanchez-Martin P, Sanchez-Martin F, Gonzalez-Martinez M, Gosalvez J. Increased pregnancy after reduced male abstinence. Syst Biol Reprod Med. 2013 Oct;59(5):256-60. doi: 10.3109/19396368.2013.790919. Epub 2013 May 8.
citation: Kang H. The prevention and handling of the missing data. Korean J Anesthesiol. 2013 May;64(5):402-6. doi: 10.4097/kjae.2013.64.5.402. Epub 2013 May 24.