Female Infertility
Conditions
Keywords
Infertility, Fallopian tubes, Hysterosalpingography, Tubal flushing, Pregnancy, Live birth, Cost-effectiveness, Randomized controlled trial
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.
Interventions
DRUGLipiodol 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
ZonMw: The Netherlands Organisation for Health Research and Development
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to live birth | 6 months | Calculated from the last menstrual bleeding within 6 months after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ongoing pregnancies | 6 and 12 months | Defined as the presence of a heart beat at 10 to 12 weeks gestation |
| Number of clinical pregnancies | 12 months | Defined as gestational sac detected on ultrasonography |
| Number of miscarriages | 6 months | Presence of non-vitality on ultrasound or spontaneous loss of pregnancy |
| Number of ectopic pregnancies | 6 months | Embryo implanted outside the uterine cavity |
| Number of multiple pregnancies | 6 months | Pregnancy of two or more foetuses |
| Number of live births | 6 months | Defined as the birth of a live born baby, after 24 weeks gestation |
| Number of pregnancy complications | 6 months | e.g. pre-term birth, hypertension |
| Number of still births | 12 months | Death or loss of the baby before or during |
| Incidence of thyroid dysfunction after HSG | One month after HSG | TSH and fT4 measurement (blood test) |
| Number of cycles of artificial reproductive techniques | 6 and 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 |
Countries
Netherlands
Contacts
Primary ContactV Mijatovic
Backup ContactDanah Kamphuis
Outcome results
None listed