Clinical trial NCT03532386: Outcomes of Intra-Cytoplasmic Sperm Injection in Infertile Men With Non-tense Vaginal Hydrocele
Official title: Outcomes of Intra-Cytoplasmic Sperm Injection in Infertile Men With Non-tense Vaginal Hydrocele
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Male
Keywords: Infertility
male factor infertility
oligoasthenospermia
vaginal hydrocele
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All infertile couples with male factor (oligoasthenospermia) due to non-tense hydrocele

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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 2 weeks after ICSI
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
state: Algharbia
Study officials:
References: