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Infertility, MaleVaricoceleNCT04608864

Varicocele Repair for Men Undergoing IVF/ICSI

A study testing varicocelectomy in people with Infertility, Male, run by Al-Yasmeen Fertility and Gynecology Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 years, men only
Conditions the study is for
Infertility, Male
What is being tested?
varicocelectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
No sites listed yet
Study dates
1 Dec 2020to 1 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Mohamed Fawzy, Ph.D contact

+201011122286

drfawzy001@me.com

Yasmin Magdi contact

+201282313979

Yas.magdi@hotmail.com

About this study

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

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.

Read the 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.

Being tested
varicocelectomy
Medical subject headings
Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • varicocelectomyProcedure or surgery

    Also called varicocele repair

    microsurgical subinguinal varicocelectomy

Study groups in NCT04608864
Study groupRoleWhat they receive
varicocelectomy armExperimentalThe varicocelectomy procedure will be performed three months before ICSI for men with with male-factor infertility and were diagnosed clinically with varicocele
Receives: Procedure: varicocelectomy
Control (No varicocelectomy) armNo interventionCouples with male-factor infertility and males were diagnosed clinically with varicocele will undergo ICSI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Livebirth rate

    the percentage of women who underwent randomization and will have a livebirth after at least 37 completed weeks of gestation

    Measured: up to 37 weeks

Secondary outcomes (10)

  1. Biochemical pregnancy

    positive βhCG ≥10 IU/L at 14 days after egg retrieval

    Measured: up to 2 weeks

  2. Clinical pregnancy

    registered sacs with a heartbeat on ultrasound >7th week of gestation

    Measured: up to 7 weeks

  3. Ongoing pregnancy

    Measured: up to 20 weeks

  4. Miscarriage

    Measured: up to 20th weeks

  5. stillbirth

    intrauterine death at >20 weeks

    Measured: up to 20 weeks

  6. Fertilization rate

    number of oocytes fertilized per oocytes retrieved

    Measured: up to 16-18 hours after ICSI

  7. Top quality embryos

    number of top quality embryos at Day 3 per number of fertilized oocytes

    Measured: up to 3 days after ICSI

  8. cryopreservation rate

    number of embryos cryopreserved per randomized woman

    Measured: up to 3-6 days after ICSI

  9. Blastocyst formation rate

    number of blastocyst at Day 5 or 6 per number of fertilized oocytes

    Measured: up to 5 or 6 days after ICSI

  10. implantation rate

    number of intrauterine gestational sacs detected by ultrasound over the total number of embryos transferred

    Measured: up to 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start1 Dec 2020 (estimated)
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04608864
Sponsor's protocol ID
008-2020
Acronym
Varicocele
Status last verified
Oct 2020
First submitted
11 Oct 2020
Last updated
29 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 28865536

  • 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.

    PubMed 27526630

  • 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.

    PubMed 25458620

Questions about this trial

What is this clinical trial studying?

A study testing varicocelectomy in people with Infertility, Male, run by Al-Yasmeen Fertility and Gynecology Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Fawzy, Ph.D (+201011122286, drfawzy001@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Livebirth rate (time frame: up to 37 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04608864, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.

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