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What is the Best Moment for Performing an HSG in Women With a Unfulfilled Childwish

NCT05608590 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2023-05-06

No results posted yet for this study

Summary

The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology.

Conditions

  • Female Infertility

Interventions

DRUG

Lipiodol UltraFluid

The investigational product is an oil-based contrast medium, Lipiodol® (Guerbet). Lipiodol® is a solution of ethyl esters of iodized fatty acids of poppy seed oil equivalent to 480mg I /ml and is a licensed contrast agent in the Netherlands (RVG 02806, see SmPC D2). The maximum amount of Lipiodol® per HSG procedure is 15 ml.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2025-12-01
Completion
2026-01-01

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608590 on ClinicalTrials.gov