Clinical trial NCT05608590: What is the Best Moment for Performing an HSG in Women With a Unfulfilled Childwish
Official title: Tubal Flushing With Oil-based Contrast During HSG in Subfertile Women: Is Early Flushing Effective and Cost-effective as Compared to Delayed Flushing? - H2Oil-timing Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Female Infertility
Keywords: Infertility
Fallopian tubes
Hysterosalpingography
Tubal flushing
Pregnancy
Live birth
Cost-effectiveness
Randomized controlled trial
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-11-08
Enrollment: 554
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Women with known endocrine disorders (e.g. the polycystic ovary syndrome, diabetes, hyperthyroidism and hyperprolactinemia. Except for well managed hypothyroidism with TSH 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\^6 spermatozoa/ml
* Not willing or able to sign the consent form

Primary outcomes:
measure: Time to live birth
timeFrame: 6 months
measure: Time to live birth
timeFrame: 12 months
Secondary outcomes:
measure: Number of live births
timeFrame: 6 months
measure: Number of live births
timeFrame: 12 months
measure: Number of ongoing pregnancies
timeFrame: 6 and 12 months
measure: Number of ongoing pregnancies
timeFrame: 6 months
measure: Number of clinical pregnancies
timeFrame: 12 months
measure: Number of miscarriages
timeFrame: 6 months
measure: Number of miscarriages
timeFrame: 12 months
measure: Number of ectopic pregnancies
timeFrame: 6 months
measure: Number of ectopic pregnancies
timeFrame: 12 months
measure: Number of multiple pregnancies
timeFrame: 6 months
measure: Number of multiple pregnancies
timeFrame: 12 months
measure: Number of complication after HSG
timeFrame: One month after HSG
measure: Number of pregnancy complications
timeFrame: 6 months
measure: Number of pregnancy complications
timeFrame: 12 months
measure: Number of still births
timeFrame: 12 months
measure: Number of still births
timeFrame: 6 months
measure: Incidence of thyroid dysfunction after HSG
timeFrame: One month after HSG
measure: Number of cycles of artificial reproductive techniques
timeFrame: 6 and 12 months
measure: Number of cycles of artificial reproductive techniques
timeFrame: 6 months
measure: Number of cycles of artificial reproductive techniques
timeFrame: 12 months
measure: Neonatal thyroid dysfunction
timeFrame: Within one week after birth
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam AMC
Study officials:
References: