What is the Best Moment for Performing an HSG in Women With a Unfulfilled Childwish
- Registration Number
- NCT05608590
- Lead Sponsor
- Amsterdam UMC, location VUmc
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 554
- Women between 18-39 years of age
- Spontaneous menstrual cycle
- Perceived low risk for tubal pathology
- Undergoing fertility work-up
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed HSG 6 months after completing fertility work-up Lipiodol UltraFluid Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) after a 6 months waiting period after completion of fertility work-up Direct HSG during fertility work-up Lipiodol UltraFluid Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) incorporated in the fertility work-up
- Primary Outcome Measures
Name Time Method Time to live birth 12 months Calculated from the last menstrual bleeding within 12 months after randomization
- Secondary Outcome Measures
Name Time Method Number of clinical pregnancies 12 months Defined as gestational sac detected on ultrasonography
Number of miscarriages 12 months Presence of non-vitality on ultrasound or spontaneous loss of pregnancy
Number of ectopic pregnancies 12 months Embryo implanted outside the uterine cavity
Number of live births 12 months Defined as the birth of a live born baby, after 24 weeks gestation
Number of ongoing pregnancies 6 months Defined as the presence of a heart beat at 10 to 12 weeks gestation
Incidence of thyroid dysfunction after HSG One month after HSG TSH and fT4 measurement (blood test)
Number of multiple pregnancies 12 months Pregnancy of two or more foetuses
Number of pregnancy complications 12 months e.g. pre-term birth, hypertension
Number of cycles of artificial reproductive techniques 12 months Number of cycles of IUI and IVF/ICSI
Neonatal thyroid dysfunction Within one week after birth Screening on congenital thyroid dysfunction postpartum
Number of complication after HSG One month after HSG e.g. intravasation or infection
Number of still births 6 months Death or loss of the baby before or during
Trial Locations
- Locations (1)
Amsterdam AMC
🇳🇱Amsterdam, Netherlands