Early treatment of a clinical varicocele in subfertile men results in more spontaneaous pregnancies as compared to no treatment.
ID
Bron
Verkorte titel
Aandoening
Varicocele and male subfertility
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint is spontaneous pregnancy within the 1 year follow-up period in both groups.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Early treatment of a clinical varicocele in subfertile men results in more spontaneaous pregnancies as compared to no treatment.
Onderzoeksopzet
1. Primary outcome: 1 year;
2. Secondary outcome: 3 and 6 months.
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 2040
G.R. Dohle
Rotterdam 3000 CA
The Netherlands
+31-10-7033095
g.r.dohle@erasmusmc.nl
Wetenschappelijk
P.O. Box 2040
G.R. Dohle
Rotterdam 3000 CA
The Netherlands
+31-10-7033095
g.r.dohle@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Azoospermia;
2. Normal semen analysis;
3. Other male infertility factor than varicocele;
4. Femal factor for the infertility.
Opzet
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In overige registers
Register | ID |
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NTR-new | NL1727 |
NTR-old | NTR1837 |
Ander register | MEC ErasmusMC : 139.255/1996/1 |
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