Varicocele Repair for Men Undergoing IVF/ICSI (NCT04608864) | Clinical Trial Compass
UnknownNot Applicable
Varicocele Repair for Men Undergoing IVF/ICSI
2,000 participantsStarted 2020-12-01
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexMALE
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Inclusion criteria
✓. Couples able to provide informed consent.
✓. Couples with at least 12 months of infertility
✓. Couples with male-factor infertility
✓. Couples counseled for ICSI procedure by reproductive specialist.
✓. Couples undergoing their first ICSI cycle or their second ICSI cycle after a previously successful treatment.
✓. Female: age between 18-43; body mass index (BMI) between 19.0-35.0 kg/m2; FSH level 3.0-20.0 miU/mL and/or AMH ≥1.5 pmol/L; with regular menstrual cycles (defined as 25 to 35 days in duration), evidence of ovulation (by biphasic basal body temperature, ovulation predictor kits, or luteal serum progesterone level ≥3 ng/mL), have no uterine abnormality by ultrasound; anticipated normal responder (≥5 antral follicle count or ≥5.4 pmol/L Anti- mullerian hormone (AMH).
✓. Male: age: 18-55; able to produce freshly ejaculated sperm for the treatment cycle; diagnosed with clearly palpable varicocele; have at least one abnormal semen parameter on a semen analysis in the preceding 3 months: sperm concentration ≤15 million/mL (oligospermia), total motility≤40% (asthenospermia), or normal morphology ≤4% (teratospermia); normal hormonal profile
Exclusion criteria
✕. Patients who willing to undergo ICSI with preimplantation genetic diagnosis.
✕. Female: have previous two cycles of implantation failure at fresh transfer; with unilateral oophorectomy; PCOs; have any uterine pathology (myomas, adenomyosis, endocrinopathies, thrombophilia, chronic pathologies, acquired or congenital uterine abnormalities); have severe endometriosis; have uni- or bilateral hydrosalpinx; have history of recurrent pregnancy loss, takes any medical condition that affect fertility.
✕. Male: have varicocele associated with hydrocele or inguinal hernia; secondary and recurrent varicocele, varicocele complicated by thrombophlebitis; varicocele with infertility due to other causes (demonstrated by andrologists), if they have a sperm concentration \<1 million/mL on the screening semen analysis or if they were taking fertility medication or testosterone. Men are required to refrain from taking any medications for 4 weeks before randomization.
✕. Abnormal karyotyping for female or male partners.
✕. Uncontrolled diabetes, liver or renal disease, history of malignancy or borderline pathology of male or female partners.