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

NCT ID: NCT03532386

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Infertility, Male

Keywords

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Infertility male factor infertility oligoasthenospermia vaginal hydrocele

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Infertile men with oligoasthenospermia with non-tense vaginal hydrocele subjected to ICSI

ICSI

Intervention Type PROCEDURE

ICSI for both couples

Control group

infertile men with oligoasthenospermia without hydrocele subjected to ICSI

ICSI

Intervention Type PROCEDURE

ICSI for both couples

Interventions

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ICSI

ICSI for both couples

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ayman S Dawood, MD

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ayman Shehata Dawood

Tanta, Algharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Salah A Naglah

Identifier Type: OTHER

Identifier Source: secondary_id

Ayman Shehata

Identifier Type: -

Identifier Source: org_study_id