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

Does treatment of a varicocele in subfertile men result in more spontaneous pregnancies? A randomized controlled trial comparing treatment to no treatment.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21167
Enrollment
130
Registered
2009-06-04
Start date
1998-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicocele and male subfertility

Interventions

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.

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

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 1 year.

Exclusion criteria

Exclusion criteria: 1. Azoospermia; 2. Normal semen analysis; 3. Other male infertility factor than varicocele; 4. Femal factor for the infertility.

Design outcomes

Primary

MeasureTime frame
Primary endpoint is spontaneous pregnancy within the 1 year follow-up period in both groups.

Secondary

MeasureTime frame
Secundairy endpoints are improvement of semen in both groups and predictive factors for a spontaneous pregnancy.

Contacts

Public ContactG.R. Dohle

Erasmus MC P.O. Box 2040

g.r.dohle@erasmusmc.nl+31-10-7033095

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)