No registrations found.
ID
Source
Brief title
Health condition
Varicocele and male subfertility
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is spontaneous pregnancy within the 1 year follow-up period in both groups.
Secondary outcome
Secundairy endpoints are improvement of semen in both groups and predictive factors for a spontaneous pregnancy.
Background summary
Varicocele 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.
Study objective
Early treatment of a clinical varicocele in subfertile men results in more spontaneaous pregnancies as compared to no treatment.
Study design
1. Primary outcome: 1 year;
2. Secondary outcome: 3 and 6 months.
Intervention
The 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.
P.O. Box 2040
G.R. Dohle
Rotterdam 3000 CA
The Netherlands
+31-10-7033095
g.r.dohle@erasmusmc.nl
P.O. Box 2040
G.R. Dohle
Rotterdam 3000 CA
The Netherlands
+31-10-7033095
g.r.dohle@erasmusmc.nl
Inclusion criteria
1. 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 criteria
1. Azoospermia;
2. Normal semen analysis;
3. Other male infertility factor than varicocele;
4. Femal factor for the infertility.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1727 |
| NTR-old | NTR1837 |
| Other | MEC ErasmusMC : 139.255/1996/1 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |