Varicocele Repair for Men Undergoing IVF/ICSI

Infertility, Male Clinical Trial

— Varicocele  

Official title:

Varicocele Repair for Infertile Men Undergoing IVF/ICSI: a Parallel, Two-group, Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04608864
• Other study ID #: 008-2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2020
• Source: Al-Yasmeen Fertility and Gynecology Center
• Contact: Mohamed Fawzy, Ph.D
• Phone: +201011122286
• Email: drfawzy001[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: August 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Couples able to provide informed consent.

2. Couples with at least 12 months of infertility

3. Couples with male-factor infertility

4. Couples counseled for ICSI procedure by reproductive specialist.

5. Couples undergoing their first ICSI cycle or their second ICSI cycle after a previously successful treatment.

6. 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).

7. 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:

1. Patients who willing to undergo ICSI with preimplantation genetic diagnosis.

2. 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.

3. 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.

4. Abnormal karyotyping for female or male partners.

5. Uncontrolled diabetes, liver or renal disease, history of malignancy or borderline pathology of male or female partners.

6. Previous participation in the trial.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Varicocele

Intervention

Procedure:
• varicocelectomy
microsurgical subinguinal varicocelectomy

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Al-Yasmeen Fertility and Gynecology Center	Amshaj IVF Center, Banon IVF Center Assiut, Egypt, Elite Fertility and Gynecology Center, Cairo, Egypt, IbnSina IVF Center, Sohag, Egypt, Qena IVF Centre, Qena, Egypt

References & Publications (3)

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. F — View Citation

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. Review. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Biochemical pregnancy	positive ßhCG =10 IU/L at 14 days after egg retrieval	up to 2 weeks
Secondary	Clinical pregnancy	registered sacs with a heartbeat on ultrasound >7th week of gestation	up to 7 weeks
Secondary	Ongoing pregnancy		up to 20 weeks
Secondary	Miscarriage		up to 20th weeks
Secondary	stillbirth	intrauterine death at >20 weeks	up to 20 weeks
Secondary	Fertilization rate	number of oocytes fertilized per oocytes retrieved	up to 16-18 hours after ICSI
Secondary	Top quality embryos	number of top quality embryos at Day 3 per number of fertilized oocytes	up to 3 days after ICSI
Secondary	cryopreservation rate	number of embryos cryopreserved per randomized woman	up to 3-6 days after ICSI
Secondary	Blastocyst formation rate	number of blastocyst at Day 5 or 6 per number of fertilized oocytes	up to 5 or 6 days after ICSI
Secondary	implantation rate	number of intrauterine gestational sacs detected by ultrasound over the total number of embryos transferred	up to 7 weeks