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

Infertility, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532386
• Other study ID #: Ayman Shehata
• Secondary ID: Salah A Naglah
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: December 2018
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Testicular Hydrocele

Intervention

Procedure:
• ICSI
ICSI for both couples

Locations

Country	Name	City	State
Egypt	Ayman Shehata Dawood	Tanta	Algharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate	Success of ICSI with positive pregnancy test in serum	2 weeks after ICSI