An interventional study of varicocelectomy in Infertility, Male, sponsored by Al-Yasmeen Fertility and Gynecology Center. Status unknown. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by Al-Yasmeen Fertility and Gynecology Center · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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.
282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 80 across 187 interventional studies indexed under Infertility, Male.
Browse Infertility, Male studies →Al-Yasmeen Fertility and Gynecology Center is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Couples with male-factor infertility and males were diagnosed clinically with varicocele will undergo ICSI
microsurgical subinguinal varicocelectomy
Also known as: varicocele repair
Livebirth rate
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
Biochemical pregnancy
positive βhCG ≥10 IU/L at 14 days after egg retrieval
Time frame: up to 2 weeks
Clinical pregnancy
registered sacs with a heartbeat on ultrasound \>7th week of gestation
Time frame: up to 7 weeks
Ongoing pregnancy
Time frame: up to 20 weeks
Miscarriage
Time frame: up to 20th weeks
stillbirth
intrauterine death at \>20 weeks
Time frame: up to 20 weeks
Fertilization rate
number of oocytes fertilized per oocytes retrieved
Time frame: up to 16-18 hours after ICSI
Top quality embryos
number of top quality embryos at Day 3 per number of fertilized oocytes
Time frame: up to 3 days after ICSI
cryopreservation rate
number of embryos cryopreserved per randomized woman
Time frame: up to 3-6 days after ICSI
Blastocyst formation rate
number of blastocyst at Day 5 or 6 per number of fertilized oocytes
Time frame: up to 5 or 6 days after ICSI
implantation rate
number of intrauterine gestational sacs detected by ultrasound over the total number of embryos transferred
Time frame: up to 7 weeks
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 3-6 months
Start is estimated for Dec 2020; primary completion for Dec 2022, 24 months later.
Of 77 non-industry interventional studies with no phase under Infertility, Male, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's planned 24 months is below that.
Counting every sponsor, half of 92 studies reached it within 34 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Al-Yasmeen Fertility and Gynecology Center