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

Study Overview

• Status: Completed
• Conditions: Infertility, Male
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Algharbia
    • Tanta, Algharbia, Egypt, 31111
      • Ayman Shehata Dawood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All infertile couples with male factor (oligoasthenospermia) due to non-tense hydrocele

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Infertile men with oligoasthenospermia with non-tense vaginal hydrocele subjected to ICSI	Procedure: ICSI; ICSI for both couples
Control group; infertile men with oligoasthenospermia without hydrocele subjected to ICSI	Procedure: ICSI; ICSI for both couples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	Success of ICSI with positive pregnancy test in serum	2 weeks after ICSI

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (ACTUAL): May 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 9, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Infertility; male factor infertility; oligoasthenospermia; vaginal hydrocele
• Additional Relevant MeSH Terms: Infertility; Infertility, Male; Testicular Hydrocele
• Other Study ID Numbers: Ayman Shehata; Salah A Naglah (OTHER: Tanta University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not accepted to share patient data only results of study to be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No