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Oil- versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial (H2Oil-2 study)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512571-12-00
Acronym
NL66079.029.18
Enrollment
499
Registered
2024-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-29

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

Conditions

Infertility

Brief summary

The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.

Detailed description

Biochemical pregnancy, Clinical pregnancy, Ongoing pregnancy, Miscarriage, Ectopic pregnancy, Multiple pregnancy, Time to pregnancy, Complications following HSG (infection, intravastion), Pregnancy outcomes (f.e. birth weight), Pregnancy complications, Stillbirth, Thyroid function of the woman (before and 1 month after HSG), Neonatal outcomes, Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI), Costs within 6 months after randomization, Thyroid function of neonate (determined by heelprick)

Interventions

DRUGVISIPAQUE 320 mg I/ml
DRUGoplossing voor injectie
DRUGLipiodol Ultra Fluide
DRUGoplossing voor injectie.

Sponsors

Amsterdam UMC Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary outcome is conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization.

Secondary

MeasureTime frame
Biochemical pregnancy, Clinical pregnancy, Ongoing pregnancy, Miscarriage, Ectopic pregnancy, Multiple pregnancy, Time to pregnancy, Complications following HSG (infection, intravastion), Pregnancy outcomes (f.e. birth weight), Pregnancy complications, Stillbirth, Thyroid function of the woman (before and 1 month after HSG), Neonatal outcomes, Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI), Costs within 6 months after randomization, Thyroid function of neonate (determined by heelprick)

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026