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Completed

NCT Number: NCT03532386

Outcomes of Intra-Cytoplasmic Sperm Injection in Infertile Men With Non-tense Vaginal Hydrocele

Infertile men due to oligoasthenospermia with non-tense hydroceles are subjected to ICSI

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Key information

Conditions

Infertility, Male Endocrine System Diseases Genital Diseases Genital Diseases, Male Gonadal Disorders Infertility Male Urogenital Diseases Testicular Diseases Testicular Hydrocele Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ayman Shehata Dawood

Tanta, Algharbia, 31111, Egypt

About this study

Sixty male infertile patients with Oligoasthenospermia were recruited from outpatient clinic of Urology Department, Tanta University. Patients were selected according to inclusion and exclusion criteria. The inclusion criteria were: (a) infertile couples due to male factor (b) Oligoasthenospermia (c) Normal hormonal profile (serum free and total testosterone, prolactin, Estrogen and LH), (d) presence or absence of non-tense vaginal hydrocel. The exclusion criteria were: (a) Presence of varicocele, (b) History of recent testicular trauma, (c) History of recent or old testicular inflammation, (d) Tense vaginal hydrocele and (e) presence of potential female pathologies.

Sample size calculation: With H0 denoting higher success rates for ICSI in absence of non-tense hydrocele and confidence level of 95% and interval of 5 the sample size was 30. The program used was Epi info 0.7.

Randomization and allocation: Enrolled patients were randomly allocated into 2 groups. The first group (n=30) who have oligoasthenospermia with non-tense vaginal hydrocele (Study group) and the second group (n=30) who have oligoasthenospermia with no hydrocele group (Control group). Randomization was done by computer-generated serial numbers where each number was enveloped. Each number denotes a certain allocation group. Allocation was by alternate method and envelope opening did not change allocation.

Methods: Males were assessed by genital examination, ultrasound and scrotal Doppler. Female partners were given long agonist stimulation protocols, Ovum pickup fertilization by sperms and then embryo transfer on day 5. Demographic data of both couples, duration of infertility, seminal parameters (WHO-2010) and results of ICSI in these couples were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infertile couples due to male factor
  • Oligoasthenospermia
  • Normal hormonal profile (serum free and total testosterone, prolactin, Estrogen and LH)
  • Presence or absence of non-tense vaginal hydrocele

Exclusion criteria

  • Presence of varicocele
  • History of recent testicular trauma
  • History of recent or old testicular inflammation
  • Tense vaginal hydrocele
  • Presence of potential female pathology

Treatment and study plan

ICSI

Procedure

ICSI for both couples

Primary outcomes

  1. clinical pregnancy rate

    Time frame: 2 weeks after ICSI

    Success of ICSI with positive pregnancy test in serum

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 22, 2018
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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