NCT04608864

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

October 11, 2020

Last Update Submit

October 28, 2020

Conditions

Infertility, Male

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Biochemical pregnancy

    up to 2 weeks

  • Clinical pregnancy

    up to 7 weeks

  • Ongoing pregnancy

    up to 20 weeks

  • Miscarriage

    up to 20th weeks

  • stillbirth

    up to 20 weeks

  • +5 more secondary outcomes

Study Arms (2)

varicocelectomy arm

EXPERIMENTAL

The varicocelectomy procedure will be performed three months before ICSI for men with with male-factor infertility and were diagnosed clinically with varicocele

Procedure: varicocelectomy

Control (No varicocelectomy) arm

NO INTERVENTION

Couples with male-factor infertility and males were diagnosed clinically with varicocele will undergo ICSI

Interventions

varicocelectomyPROCEDURE

microsurgical subinguinal varicocelectomy

Also known as: varicocele repair
varicocelectomy arm

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28865536RESULT

  • 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.

    PMID: 27526630RESULT

  • 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.

    PMID: 25458620RESULT

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Mohamed Fawzy, Ph.D

    IbnSina IVF Center, IbnSina Hospital, Sohag

    STUDY DIRECTOR

Central Study Contacts

Mohamed Fawzy, Ph.D

CONTACT

+201011122286drfawzy001@me.com

Yasmin Magdi

CONTACT

+201282313979Yas.magdi@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2020

First Posted

October 29, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2022

Study Completion

August 1, 2023

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
3-6 months