what is the best moment for performing an hsg in women with a unfulfilled childwish

Conditions: Female Infertility

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.

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

Keywords: infertility fallopian tubes hysterosalpingography tubal flushing pregnancy live birth cost-effectiveness randomized controlled trial