Abstinence Period and Semen Quality

NCT04955782 | Unknown DMC

• 1 other identifier: 2104-MUS-006-US
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility, Male

Keywords

infertilty; semen analysis; semen parameters; progressive motility; abstinence period; sperm count

Outcome Measures

Primary Outcomes (7)

• 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)

  1 day

• Ejaculate volume

  Ejaculate volume in ml

  1 day

• Sperm viability

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

  1 day

• Sperm motility

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

  1 day

• Sperm count

  Sperm count in mill/ml

  1 day

• Sperm concentration

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

  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

  1 day

Study Arms (2)

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

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

Interventions

samples will be analyzed for semen volume, pH, count, concentration, motility, morphology and viability BEHAVIORAL

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; 62-84 hours of abstinence

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics LLC

Muscat, Oman

RECRUITING

Related Publications (6)

• 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.

  PMID: 11980755 BACKGROUND

• 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.

  PMID: 15236990 BACKGROUND

• 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.

  PMID: 27196032 BACKGROUND

• 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.

  PMID: 30570220 BACKGROUND

• 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.

  PMID: 23651301 BACKGROUND

• 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.

  PMID: 23741561 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

semen sample

MeSH Terms

Conditions

Infertility, Male

Interventions

Hydrogen-Ion Concentration; Cell Movement

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemical Phenomena; Cell Physiological Phenomena; Locomotion; Movement; Physiological Phenomena

Study Officials

• Upma Pathak Shanker, Specialist

  ART Fertility Clinics LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BARBARA LAWRENZ, PhD

CONTACT

026528000; barbara.lawrenz@artfertilityclinics.com

SHIERYL DIGMA, RN

CONTACT

026528000; shieryl.digma@artfertilityclinics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 9, 2021
• Study Start: September 16, 2021
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

OM (1)