Varicocele Repair for Men Undergoing IVF/ICSI (Varicocele)
Primary Purpose
Infertility, Male
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
varicocelectomy
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Male
Eligibility Criteria
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.
- Previous participation in the trial.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
varicocelectomy arm
Control (No varicocelectomy) arm
Arm Description
The varicocelectomy procedure will be performed three months before ICSI for men with with male-factor infertility and were diagnosed clinically with varicocele
Couples with male-factor infertility and males were diagnosed clinically with varicocele will undergo ICSI
Outcomes
Primary Outcome Measures
Livebirth rate
the percentage of women who underwent randomization and will have a livebirth after at least 37 completed weeks of gestation
Secondary Outcome Measures
Biochemical pregnancy
positive βhCG ≥10 IU/L at 14 days after egg retrieval
Clinical pregnancy
registered sacs with a heartbeat on ultrasound >7th week of gestation
Ongoing pregnancy
Miscarriage
stillbirth
intrauterine death at >20 weeks
Fertilization rate
number of oocytes fertilized per oocytes retrieved
Top quality embryos
number of top quality embryos at Day 3 per number of fertilized oocytes
cryopreservation rate
number of embryos cryopreserved per randomized woman
Blastocyst formation rate
number of blastocyst at Day 5 or 6 per number of fertilized oocytes
implantation rate
number of intrauterine gestational sacs detected by ultrasound over the total number of embryos transferred
Full Information
NCT ID
NCT04608864
First Posted
October 11, 2020
Last Updated
October 28, 2020
Sponsor
Al-Yasmeen Fertility and Gynecology Center
Collaborators
Elite Fertility and Gynecology Center, Cairo, Egypt, Banon IVF Center Assiut, Egypt, IbnSina IVF Center, Sohag, Egypt, Qena IVF Centre, Qena, Egypt, Amshaj IVF Center
1. Study Identification
Unique Protocol Identification Number
NCT04608864
Brief Title
Varicocele Repair for Men Undergoing IVF/ICSI
Acronym
Varicocele
Official Title
Varicocele Repair for Infertile Men Undergoing IVF/ICSI: a Parallel, Two-group, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Yasmeen Fertility and Gynecology Center
Collaborators
Elite Fertility and Gynecology Center, Cairo, Egypt, Banon IVF Center Assiut, Egypt, IbnSina IVF Center, Sohag, Egypt, Qena IVF Centre, Qena, Egypt, Amshaj IVF Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
varicocelectomy arm
Arm Type
Experimental
Arm Description
The varicocelectomy procedure will be performed three months before ICSI for men with with male-factor infertility and were diagnosed clinically with varicocele
Arm Title
Control (No varicocelectomy) arm
Arm Type
No Intervention
Arm Description
Couples with male-factor infertility and males were diagnosed clinically with varicocele will undergo ICSI
Intervention Type
Procedure
Intervention Name(s)
varicocelectomy
Other Intervention Name(s)
varicocele repair
Intervention Description
microsurgical subinguinal varicocelectomy
Primary Outcome Measure Information:
Title
Livebirth rate
Description
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
Secondary Outcome Measure Information:
Title
Biochemical pregnancy
Description
positive βhCG ≥10 IU/L at 14 days after egg retrieval
Time Frame
up to 2 weeks
Title
Clinical pregnancy
Description
registered sacs with a heartbeat on ultrasound >7th week of gestation
Time Frame
up to 7 weeks
Title
Ongoing pregnancy
Time Frame
up to 20 weeks
Title
Miscarriage
Time Frame
up to 20th weeks
Title
stillbirth
Description
intrauterine death at >20 weeks
Time Frame
up to 20 weeks
Title
Fertilization rate
Description
number of oocytes fertilized per oocytes retrieved
Time Frame
up to 16-18 hours after ICSI
Title
Top quality embryos
Description
number of top quality embryos at Day 3 per number of fertilized oocytes
Time Frame
up to 3 days after ICSI
Title
cryopreservation rate
Description
number of embryos cryopreserved per randomized woman
Time Frame
up to 3-6 days after ICSI
Title
Blastocyst formation rate
Description
number of blastocyst at Day 5 or 6 per number of fertilized oocytes
Time Frame
up to 5 or 6 days after ICSI
Title
implantation rate
Description
number of intrauterine gestational sacs detected by ultrasound over the total number of embryos transferred
Time Frame
up to 7 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Previous participation in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Fawzy, Ph.D
Phone
+201011122286
Email
drfawzy001@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Magdi
Phone
+201282313979
Email
Yas.magdi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Fawzy, Ph.D
Organizational Affiliation
IbnSina IVF Center, IbnSina Hospital, Sohag
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
3-6 months
Citations:
PubMed Identifier
28865536
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.
Results Reference
result
PubMed Identifier
27526630
Citation
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.
Results Reference
result
PubMed Identifier
25458620
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 2014 Nov 25.
Results Reference
result
Learn more about this trial
Varicocele Repair for Men Undergoing IVF/ICSI
We'll reach out to this number within 24 hrs