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| ID | Type | Description | Link |
|---|---|---|---|
| 2018.004153.24 | EudraCT Number | ||
| NL7926 | Other Identifier | NTR |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct HSG during fertility work-up | Experimental | Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) incorporated in the fertility work-up |
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| Delayed HSG 6 months after completing fertility work-up | Active Comparator | Tubal flushing at HSG with Lipiodol® (oil-based contrast medium) (max. 15mL) after a 6 months waiting period after completion of fertility work-up |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipiodol UltraFluid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to live birth | Calculated from the last menstrual bleeding within 6 months after randomization | 6 months |
| Time to live birth | Calculated from the last menstrual bleeding within 12 months after randomization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of live births | Defined as the birth of a live born baby, after 24 weeks gestation | 6 months |
| Number of live births | Defined as the birth of a live born baby, after 24 weeks gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| V Mijatovic | Contact | +312044444567 | mijatovic@amsterdamumc.nl | |
| Danah Kamphuis | Contact | +312044444567 | d.kamphuis@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam AMC | Recruiting | Amsterdam | 1081HV | Netherlands |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004998 | Ethiodized Oil |
| ID | Term |
|---|---|
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 |
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| 12 months |
| Number of ongoing pregnancies | Defined as the presence of a heart beat at 10 to 12 weeks gestation | 6 and 12 months |
| Number of ongoing pregnancies | Defined as the presence of a heart beat at 10 to 12 weeks gestation | 6 months |
| Number of clinical pregnancies | Defined as gestational sac detected on ultrasonography | 12 months |
| Number of miscarriages | Presence of non-vitality on ultrasound or spontaneous loss of pregnancy | 6 months |
| Number of miscarriages | Presence of non-vitality on ultrasound or spontaneous loss of pregnancy | 12 months |
| Number of ectopic pregnancies | Embryo implanted outside the uterine cavity | 6 months |
| Number of ectopic pregnancies | Embryo implanted outside the uterine cavity | 12 months |
| Number of multiple pregnancies | Pregnancy of two or more foetuses | 6 months |
| Number of multiple pregnancies | Pregnancy of two or more foetuses | 12 months |
| Number of complication after HSG | e.g. intravasation or infection | One month after HSG |
| Number of pregnancy complications | e.g. pre-term birth, hypertension | 6 months |
| Number of pregnancy complications | e.g. pre-term birth, hypertension | 12 months |
| Number of still births | Death or loss of the baby before or during | 12 months |
| Number of still births | Death or loss of the baby before or during | 6 months |
| Incidence of thyroid dysfunction after HSG | TSH and fT4 measurement (blood test) | One month after HSG |
| Number of cycles of artificial reproductive techniques | Number of cycles of IUI and IVF/ICSI | 6 and 12 months |
| Number of cycles of artificial reproductive techniques | Number of cycles of IUI and IVF/ICSI | 6 months |
| Number of cycles of artificial reproductive techniques | Number of cycles of IUI and IVF/ICSI | 12 months |
| Neonatal thyroid dysfunction | Screening on congenital thyroid dysfunction postpartum | Within one week after birth |
| D000091662 | Genital Diseases |
| Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |