Infertility
Conditions
Keywords
Hysterosalpingography, Hysterosalpingo Foam Sonography, Infertility work-up, Cost-effectiveness, Live birth, Randomized controlled trial
Brief summary
Hysterosalpingography (HSG) and hysterosalpingo-foam sonography are two methods to assess tubal patency during fertility work-up. This study aims to investigate the effectiveness of tubal flushing with oil-based contrast during HSG compared to tubal flushing during HyFoSy in women undergoing fertility work-up. The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births than tubal flushing during HyFoSy.
Detailed description
Background: The diagnostic work-up for infertility generally includes estimating the risk for tubal pathology and if indicated assessing tubal patency. Traditionally, tubal patency testing during the fertility work-up is performed with hysterosalpingography (HSG). In previous studies it has been demonstrated that tubal flushing with oil-based contrast during HSG resulted in more ongoing pregnancies than when HSG is performed with water-based contrast. HyFoSy is a more patient friendly alternative for HSG. Up till now, the fertility enhancing effect of tubal flushing with ExEm Foam during HyFoSy has only been studied in relatively small and observational studies. Objectives:The main objective of this study is to determine whether tubal flushing with oil-based contrast during HSG results into more pregnancies leading to live births when compared to tubal flushing with ExEm Foam during HyFoSy, and whether this approach is cost-effective. In this study the safety of both strategies will also be compared. Rationale: The hypothesis is that tubal flushing with oil-based contrast during HSG leads to more live births compared to tubal flushing with ExEm Foam during HyFoSy in women with an indication for tubal patency testing. If more live births are achieved, expensive fertility treatments will be less needed, which makes tubal flushing with oil-based contrast during HSG a cost-effective strategy. Study design: This study is a multicenter randomized controlled trial with an economic analysis alongside it. Women with indication for tubal patency testing will be randomized to tubal flushing with oil-based contrast during HSG and tubal flushing with ExEm Foam during HyFoSy.
Interventions
PROCEDUREOil-based contrast
oil-based contrast fluid, Lipiodol Ultra Fluid. Lipiodol is a solution of iodinated ethyl esters of fatty acids of poppyseed oil. Equivalent to 480 mg iodine per ml. The maximum dosage is 15ml. Lipiodol is produced by Guerbet, France. Lipiodol is FDA approved and registered as contrast agent for HSG.
PROCEDUREExEm Foam
ExEm Foam which is created by mixing 5ml ExEm-gel and 5ml of purified water. ExEm-gel contains hydroxyethylcellulose and glycerol. The ExEm Foam is distributed by IQ Medical Ventures, the Netherlands. ExEm Foam is FDA approved, CE marked and registered as contrast agent for HyFoSy.
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 42 Years
Healthy volunteers
No
Inclusion criteria
* Infertile women or women with oligo-or anovulation * Indication for tubal patency testing during the fertility work-up * Sufficient understanding of the Dutch or English language * Signed informed consent
Exclusion criteria
* Severe male factor with a total motile sperm count \<3x106ml (pre-washed) * Known contrast (iodine) allergy * Women who have had a gynecologic procedure within the last 30 days * Women with known or suspected reproductive tract neoplasia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of pregnancies leading to live birth. | within six months after randomization | Pregnancy is defined as a positive pregnancy test, increase in human chorionic gonadotropin (HCG) level or a pregnancy shown on ultrasonographic examination. Live birth is defined as the birth of live baby born beyond 24 weeks of pregnancy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of clinical pregnancies | within six months after randomization | Clinical pregnancy is defined as gestational sac with or without heartbeat visible on ultrasound. |
| Number of miscarriages | within six months after randomization | Miscarriage is defined as presence of non-vitality on ultrasound or spontaneous loss off pregnancy |
| Number of multiple pregnancies | within six months after randomization | Multiple pregnancy is defined as two or more vital intrauterine pregnancies at 12 weeks gestation. |
| Number of ectopic pregnancies | within six months after randomization | Ectopic pregnancy is defined as no intrauterine gestational sac with: an ectopic gestational sac OR HCG concentration \>1500 international units per liter (IU/L) with free fluid/ectopic mass on ultrasound or serum HCG \>2000IU/L without free fluid/ectopic mass on ultrasound |
| Time to pregnancy leading to live birth | within six months after randomization | Calculated from the day of randomization till the first day of the last menstrual bleeding before a positive pregnancy test. |
| Procedural pain scores | Within 15 minutes after tubal patency testing | measured by Visual Analogue Scale (VAS) on a scale from 0.0 to 10.0 centimeter immediately after tubal patency testing. |
| Number of fertility treatment cycles | within six months after randomization | e.g. intra uterine insemination, in vitro fertilization, intracytoplasmatic sperm injection |
| Number of pregnancy complications | within six months after randomization | e.g. pregnancy induced hypertension, fetal growth restriction, still birth. |
| Cost-effectiveness | within six months after randomization | Comparing the costs (including costs for tubal patency testing and additional fertility treatments) and the effects (chance of live birth) |
| Number of adverse events | within one months after tubal patency testing | e.g. infection, intravasation, thyroid dysfunction |
Countries
Netherlands
Contacts
Primary ContactDanah Kamphuis, Msc
Backup ContactVelja Mijatovic, Prof
Outcome results
None listed