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

Phase

Condition

Hot Flash

Infertility

Hypogonadism

Treatment

Lipiodol UltraFluid

Clinical Study ID

NCT05608590

NL62838.029.18

2018.004153.24

NL7926

Ages 18-39
Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Women between 18-39 years of age
Spontaneous menstrual cycle
Perceived low risk for tubal pathology
Undergoing fertility work-up

Exclusion

Exclusion Criteria:

Women with known endocrine disorders (e.g. the polycystic ovary syndrome, diabetes,hyperthyroidism and hyperprolactinemia. Except for well managed hypothyroidism withTSH between 0.3 and 2.5mIU/l)
Ovulation disorders defined as less than eight menstrual cycles per year
Iodine allergy
Male subfertility defined as a post-wash total motile sperm count < 1 x10^6spermatozoa/ml
Not willing or able to sign the consent form

Study Design

Lipiodol UltraFluid

August 22, 2019

January 01, 2026

Study Description

Rationale: The investigators hypothesize that 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 compared to delayed tubal flushing 6 months after fertility work-up is completed in women at low risk for tubal pathology, which will lead to a reduction in the need for expensive fertility treatments like IVF and/or ICSI, and will therefore be an effective and cost effective strategy.

Objective: 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.

Study design: The investigators plan a multicentre randomized controlled trial with an economic analysis alongside it. Infertile women at low risk for tubal pathology will be randomized to direct tubal flushing with oil-based contrast incorporated in the fertility work-up or delayed tubal flushing 6 months after fertility work-up is completed.

Study population: Infertile women 18-38 years of age, who have a spontaneous menstrual cycle and at low risk for tubal pathology, undergoing fertility work-up.

Intervention (if applicable): Direct tubal flushing with oil-based contrast at HSG as part of the fertility work-up compared to delayed tubal flushing 6 months after the fertility work-up is completed.

Main study parameters/endpoints: The primary outcome is time to live birth, calculated from positive pregnancy test and within 12 months after randomization.

Our hypothesis is that tubal flushing at HSG with oil-based contrast incorporated in the fertility work-up will result in 10% more ongoing pregnancies and a shorter time to pregnancy, and thus reducing the need for ART and reducing costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As two strategies are compared (tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up versus 6 months after completion of fertility work-up) that are already applied in current practice, no additional risks or burdens are expected from the study.

Connect with a study center

Amsterdam AMC
Amsterdam, 1081HV
Netherlands
Active - Recruiting

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