Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
2000 participants
INTERVENTIONAL
2020-12-01
2023-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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varicocelectomy arm
The varicocelectomy procedure will be performed three months before ICSI for men with with male-factor infertility and were diagnosed clinically with varicocele
varicocelectomy
microsurgical subinguinal varicocelectomy
Control (No varicocelectomy) arm
Couples with male-factor infertility and males were diagnosed clinically with varicocele will undergo ICSI
No interventions assigned to this group
Interventions
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varicocelectomy
microsurgical subinguinal varicocelectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
MALE
No
Sponsors
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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
UNKNOWN
Amshaj IVF Center
OTHER
Al-Yasmeen Fertility and Gynecology Center
OTHER
Responsible Party
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Yasmin Magdi
Principal Investigator
Principal Investigators
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Mohamed Fawzy, Ph.D
Role: STUDY_DIRECTOR
IbnSina IVF Center, IbnSina Hospital, Sohag
Central Contacts
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References
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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.
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.
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.
Other Identifiers
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008-2020
Identifier Type: -
Identifier Source: org_study_id