Study Results
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Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2021-09-16
2022-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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62-84 hours of abstinence
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Sperm motility less than or equal to 20%.
* Sperm morphology less than 4% normal sperms.
Exclusion Criteria
* 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).
MALE
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Principal Investigators
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Upma Pathak Shanker, Specialist
Role: PRINCIPAL_INVESTIGATOR
ART Fertility Clinics LLC
Locations
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ART Fertility Clinics LLC
Muscat, , Oman
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2104-MUS-006-US
Identifier Type: -
Identifier Source: org_study_id
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