Surgery for men with varicocele and unexplained infertility
Outcomes of Varicocelectomy in Patients With Clinical Varicocele and Unexplained Infertility
NA · Kafrelsheikh University · NCT06491251
This study is testing if a specific surgery for varicocele can help men with unexplained infertility become fathers by looking at pregnancy rates and improvements in sperm quality.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | Kafrelsheikh University (other) |
| Locations | 1 site (Kafr ash Shaykh) |
| Trial ID | NCT06491251 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of bilateral subinguinal microscopic varicocelectomy in men experiencing unexplained infertility associated with clinical varicocele. The primary goal is to assess pregnancy outcomes following the procedure, while secondary objectives include analyzing improvements in sperm DNA fragmentation, hormonal profiles, and semen parameters. The study targets men aged 18-45 who have been unable to conceive after one year of unprotected intercourse and have normal semen analysis. The surgical approach aims to minimize complications and enhance fertility rates in affected individuals.
Who should consider this trial
Good fit: Ideal candidates are men aged 18-45 with clinical varicocele and unexplained infertility who have normal semen analysis.
Not a fit: Patients with abnormal semen analysis, other urogenital diseases, or female fertility issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve fertility outcomes for men with unexplained infertility linked to varicocele.
How similar studies have performed: Previous studies have shown that microsurgical varicocelectomy can improve fertility outcomes in men with varicocele, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients unable to conceive after 12 month of regular and unprotected intercourse * Male patients aged 18 -45 years old * Normal semen analysis (concentration, motility and morphology) according to WHO criteria 2021 * Infertile men with clinical varicocele (grade II,III) subjected to varicocelectomy * No history of other congenital or acquired urogenital diseases * Primary infertility * Normal BMI (18.5-24..9) Exclusion Criteria: * History of other congenital or acquired urogenital diseases * Age outside inclusion criteria * Grade I varicocele confirmed by ultrasound ( subclinical varicocele ) * Abnormal semen analysis * Recurrent varicocele * Patient unable or unwilling to comply with follow-up schedule * Female fertility issues (anovulation , hormonal infertility, tubal factor, endometriosis)
Where this trial is running
Kafr ash Shaykh
- Kafrelsheikh University — Kafr ash Shaykh, Egypt (RECRUITING)
Study contacts
- Principal investigator: Ahmed A. Khalifa, MSc — Kafrelsheikh University
- Study coordinator: Ahmed A. Khalifa, MSc
- Email: Ahmed.med_0571@med.kfs.edu.eg
- Phone: 00201016183850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Unexplained Infertility