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| Name | Class |
|---|---|
| Elite Fertility and Gynecology Center, Cairo, Egypt | UNKNOWN |
| Banon IVF Center Assiut, Egypt | OTHER |
| IbnSina IVF Center, Sohag, Egypt | UNKNOWN |
| Qena IVF Centre, Qena, Egypt |
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For infertile men undergoing intracytoplasmic sperm injection (ICSI), data from retrospective studies suggested that varicocele repair may be beneficial and associated with improved livebirth and pregnancy rates, however, its role remains uncertain and disputed. To date, the investigators are not aware of published randomized controlled trail (RCT) that have evaluated whether varicocele repair would improve ICSI outcomes on patients with male-factor infertility.
Varicocele repair in the era of assisted reproductive technology (ART) has been a point of dispute. The American Society for Reproductive Medicine (ASRM) Practice Committee recommended has considered ART as a primary treatment for female factor, regardless of the presence of varicocele and abnormal semen parameters.
A systematic review of 7 studies involving 1,241 men with a clinical varicocele and abnormal semen parameters showed improved livebirth and pregnancy rates after varicocelectomy in infertile men undergoing IVF/ICSI. Studies included in this systematic review were retrospective nature with a considerable heterogeneity. Evidence to support varicocelectomy for men with abnormal semen analysis undergoing IVF/ICSI has therefore remained inconclusive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varicocelectomy arm | Experimental | The varicocelectomy procedure will be performed three months before ICSI for men with with male-factor infertility and were diagnosed clinically with varicocele |
|
| Control (No varicocelectomy) arm | No Intervention | Couples with male-factor infertility and males were diagnosed clinically with varicocele will undergo ICSI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varicocelectomy | Procedure | microsurgical subinguinal varicocelectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Livebirth rate | the percentage of women who underwent randomization and will have a livebirth after at least 37 completed weeks of gestation | up to 37 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical pregnancy | positive βhCG ≥10 IU/L at 14 days after egg retrieval | up to 2 weeks |
| Clinical pregnancy | registered sacs with a heartbeat on ultrasound >7th week of gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Fawzy, Ph.D | Contact | +201011122286 | drfawzy001@me.com | |
| Yasmin Magdi | Contact | +201282313979 | Yas.magdi@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Fawzy, Ph.D | IbnSina IVF Center, IbnSina Hospital, Sohag | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28865536 | Result | Kohn TP, Kohn JR, Pastuszak AW. Varicocelectomy before assisted reproductive technology: are outcomes improved? Fertil Steril. 2017 Sep;108(3):385-391. doi: 10.1016/j.fertnstert.2017.06.033. | |
| 27526630 | Result | Kirby EW, Wiener LE, Rajanahally S, Crowell K, Coward RM. Undergoing varicocele repair before assisted reproduction improves pregnancy rate and live birth rate in azoospermic and oligospermic men with a varicocele: a systematic review and meta-analysis. Fertil Steril. 2016 Nov;106(6):1338-1343. doi: 10.1016/j.fertnstert.2016.07.1093. Epub 2016 Aug 12. |
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3-6 months
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| UNKNOWN |
| Amshaj IVF Center | OTHER |
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| up to 7 weeks |
| Ongoing pregnancy | up to 20 weeks |
| Miscarriage | up to 20th weeks |
| stillbirth | intrauterine death at >20 weeks | up to 20 weeks |
| Fertilization rate | number of oocytes fertilized per oocytes retrieved | up to 16-18 hours after ICSI |
| Top quality embryos | number of top quality embryos at Day 3 per number of fertilized oocytes | up to 3 days after ICSI |
| cryopreservation rate | number of embryos cryopreserved per randomized woman | up to 3-6 days after ICSI |
| Blastocyst formation rate | number of blastocyst at Day 5 or 6 per number of fertilized oocytes | up to 5 or 6 days after ICSI |
| implantation rate | number of intrauterine gestational sacs detected by ultrasound over the total number of embryos transferred | up to 7 weeks |
| 25458620 | Result | Practice Committee of the American Society for Reproductive Medicine; Society for Male Reproduction and Urology. Report on varicocele and infertility: a committee opinion. Fertil Steril. 2014 Dec;102(6):1556-60. doi: 10.1016/j.fertnstert.2014.10.007. Epub 2014 Nov 25. |
| D052801 |
| Male Urogenital Diseases |