Skip to content

Probabilistic diagnosis for the assessment of tubal pathology in subfertile women

Probabilistic diagnosis for the assessment of tubal pathology in subfertile women - PROTUS-study

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30849
Enrollment
800
Registered
2008-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

tubal disease tubal pathologie

Interventions

Couples in whom a probability of tubal pathology based on the medical history is different from the probability based on CAT, will be randomised for immediate hydrolaparoscopy or a delay in hydrolap

Sponsors

Máxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subfertility > 12 months;Probability of spontaneous pregnancy > 30%;Discordant result of medical history and Chlamydia Antibody Titer

Exclusion criteria

Exclusion criteria: Azospermia, knwon tubal pathology

Design outcomes

Primary

MeasureTime frame
As the study aims to assess whether it is efficient to delay the hydrolaparoscopy in low risk patients with 6 months, the primary outcome in the number of ongoing pregnancies that occurs in 6 months. We hypothesize that this number will not be decreased in the group of women in whom laparoscopy is delayed.

Secondary

MeasureTime frame
Secondary outcomes are the number of (hydro)laparoscopies, number of patients in whom the diagnosis tubal pathology has been made, number of patients in whom the diagnosis tubal pathology has been delayed, and costs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)