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Does treatment of a varicocele in subfertile men result in more spontaneous pregnancies?


- candidate number5883
- NTR NumberNTR1837
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jun-2009
- Secondary IDs139.255/1996/1 MEC ErasmusMC
- Public TitleDoes treatment of a varicocele in subfertile men result in more spontaneous pregnancies?
- Scientific TitleDoes treatment of a varicocele in subfertile men result in more spontaneous pregnancies? A randomized controlled trial comparing treatment to no treatment.
- ACRONYMVaricocele trial
- hypothesisEarly treatment of a clinical varicocele in subfertile men results in more spontaneaous pregnancies as compared to no treatment.
- Healt Condition(s) or Problem(s) studiedVaricocele, Male subfertility
- Inclusion criteria1. Clinical varicocele grade 1-3;
2. Male subfertility as confirmed by the results of two abnormal semen analyses;
3. Male age 20-60;
4. Female partner < 36 years of age and without any obvious fertility problem;
5. Infertility duration > 1 year.
- Exclusion criteria1. Azoospermia;
2. Normal semen analysis;
3. Other male infertility factor than varicocele;
4. Femal factor for the infertility.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-1998
- planned closingdate1-dec-2009
- Target number of participants130
- InterventionsThe treatment group wil have a varicocele repair by surgery or embolisation with a follow-up of 1 year. The controls will have no treatment and a follow-up of 1 year.
- Primary outcomePrimary endpoint is spontaneous pregnancy within the 1 year follow-up period in both groups.
- Secondary outcomeSecundairy endpoints are improvement of semen in both groups and predictive factors for a spontaneous pregnancy.
- Timepoints1. Primary outcome: 1 year;
2. Secondary outcome: 3 and 6 months.
- Trial web siteNone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.R. Dohle
- CONTACT for SCIENTIFIC QUERIESDr. G.R. Dohle
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryVaricocele is a physical abnormality present in 10-15% of the adult male population. It is more common in men of infertile marriages, affecting 25-30% of those with abnormal semen analysis. The exact association between reduced male fertility and varicocele is unknown, but analysis of the WHO data clearly indicates that varicocele is related to semen abnormalities, decreased testicular volume and decline in Leydig cell function. Five prospective randomised studies of varicocele treatment in adults gave conflicting results, the largest of them indicating benefit (WHO-study, Hargreave et.al.).

We perform a prospective randomised trial on varicocele treatment in oligospermic men, comparing treatment to watchful waiting. 130 couples with an infertility duration of at least 1 year, are to be randomised for treatment or no treatment. All varicoceles will be confirmed by ultrasound investigation of the scrotum. Men with no other abnormalities than a varicocele and a subnormal sperm count according to the WHO-guidelines for semen analysis are included, excluding men with azoospermia. After 1 year of follow-up the couples can choose for either artificial reproductive techniques or (delayed) varicocele repair.
- Main changes (audit trail)
- RECORD4-jun-2009 - 30-sep-2009


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