search
Back to results

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
Al-Yasmeen Fertility and Gynecology Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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.

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

    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
    search

    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