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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
microsurgical subinguinal varicocelectomy
Livebirth rate
the percentage of women who underwent randomization and will have a livebirth after at least 37 completed weeks of gestation
Time frame: up to 37 weeks
Biochemical pregnancy
positive βhCG ≥10 IU/L at 14 days after egg retrieval
Time frame: up to 2 weeks
Clinical pregnancy
registered sacs with a heartbeat on ultrasound \>7th week of gestation
Time frame: up to 7 weeks
Ongoing pregnancy
Time frame: up to 20 weeks
Miscarriage
Time frame: up to 20th weeks
stillbirth
intrauterine death at \>20 weeks
Time frame: up to 20 weeks
Fertilization rate
number of oocytes fertilized per oocytes retrieved
Time frame: up to 16-18 hours after ICSI
Top quality embryos
number of top quality embryos at Day 3 per number of fertilized oocytes
Time frame: up to 3 days after ICSI
cryopreservation rate
number of embryos cryopreserved per randomized woman
Time frame: up to 3-6 days after ICSI
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blastocyst formation rate
number of blastocyst at Day 5 or 6 per number of fertilized oocytes
Time frame: 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
Time frame: up to 7 weeks