NCT05330533

Brief Summary

Evaluate the effect of recent ejaculation on scrotal duplex parameters in infertile males with varicocele

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 16, 2022

Last Update Submit

April 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of varicose vein diameter pre and post ejaculation.

    Assessment of the change in varicose vein diameter by scrotal colour doppler ultrasonography pre ejaculation and within 30 minutes post ejaculation.

    within 30 minutes post ejaculation

Secondary Outcomes (1)

  • Assessment of varicose vein reflux time pre and post ejaculation.

    Within 30 minutes post ejaculation

Interventions

Scrotal colour doppler ultrasonography

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsEffect of Recent( Ejaculation) on Scrotal Duplex Parameters in Infertile( Males) With Varicocele
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infertile male patients with scrotal varicocele aging over 18 years old.

You may qualify if:

  • Infertile male patients.
  • patients with scrotal varicocele.
  • male patients aging over 18 years old.

You may not qualify if:

  • Pyospermia.
  • Epididymitis.
  • Orchitis.
  • Anejaculation.
  • Recurrent varicocele.
  • Patients who previously underwent scrotal or inguinal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Kizilkan Y, Duran MB, Senel S, Yikilmaz TN, Akbelen B, Toksoz S. The effect of ejaculation time on varicose vein diameter and reflux level. Andrologia. 2021 Aug;53(7):e14090. doi: 10.1111/and.14090. Epub 2021 Apr 28.

    PMID: 33913191BACKGROUND
  • Bello JO, Bhatti KH, Gherabi N, Philipraj J, Narayan Y, Tsampoukas G, Shaikh N, Papatsoris A, Moussa M, Buchholz N. The usefulness of elastography in the evaluation and management of adult men with varicocele: A systematic review. Arab J Urol. 2021 Sep 16;19(3):255-263. doi: 10.1080/2090598X.2021.1964256. eCollection 2021.

    PMID: 34552777BACKGROUND
  • Senturk AB, Cakiroglu B, Yaytokgil M, Aydin C, Sungur M, Akkoc A. Effect of venous reflux time on testosterone and semen parameters of infertile males after microscopic varicocelectomy. Andrologia. 2020 Jul;52(6):e13583. doi: 10.1111/and.13583. Epub 2020 Apr 9.

    PMID: 32271466BACKGROUND
  • Sihag P, Tandon A, Pal R, Jain BK, Bhatt S, Kaur S, Sinha A. Sonography in male infertility: a look beyond the obvious. J Ultrasound. 2018 Sep;21(3):265-276. doi: 10.1007/s40477-018-0294-5. Epub 2018 Mar 28.

    PMID: 29594932BACKGROUND
  • Raveendran AV, Agarwal A. Premature ejaculation - current concepts in the management: A narrative review. Int J Reprod Biomed. 2021 Jan 25;19(1):5-22. doi: 10.18502/ijrm.v19i1.8176. eCollection 2021 Jan.

    PMID: 33553999BACKGROUND

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Mahmoud Elsebaity, Master

CONTACT

Emad eldien Ali, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator , resident doctor

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 15, 2022

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

April 15, 2022

Record last verified: 2022-03