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

Completed

• Conditions: Infertility, Male
• Interventions: Procedure: ICSI

• Registration Number: NCT03532386
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Study Start: 2018-06-01
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-09
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	ICSI	Infertile men with oligoasthenospermia with non-tense vaginal hydrocele subjected to ICSI
Control group	ICSI	infertile men with oligoasthenospermia without hydrocele subjected to ICSI

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	2 weeks after ICSI	Success of ICSI with positive pregnancy test in serum

Trial Locations

Locations (1)

Ayman Shehata Dawood; 🇪🇬 Tanta, Algharbia, Egypt