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ID
Source
Brief title
Health condition
Subfertility, tubal patency testing
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is time to live birth, calculated from positive pregnancy test and within 12 months after randomization.
Secondary outcome
- Live birth
- Clinical pregnancy, ongoing pregnancy
- Miscarriage, ectopic pregnancy, multiple pregnancy
- Complications following HSG (infection, intravasation)
- Pregnancy outcomes (f.e. birth weight)
- Pregnancy complications
- Stillbirth
- Thyroid function of the woman (before and 1 month after HSG)
- Neonatal outcomes
- Additional fertility treatments (Intra-uterine insemination, IVF, IVF/ICSI)
- Costs within 12 months after randomization
- Thyroid function of neonate (determined by heelprick)
Background summary
Rationale: We 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 andcost 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: We 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 under 39 years of age, who have a spontaneous menstrual cycle and at low risk for tubal pathology, undergoing fertility work-up.
Intervention: 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 we compare strategies (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.
Study objective
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.
Study design
Follow-up 12 months
Intervention
Direct HSG with oil-soluble contrast, incorporated in the fertility workup (intervention).
Delayed HSG with oil-soluble contrast 6 months after fertility workup (control).
Inclusion criteria
In order to be eligible to participate in this study, women must meet all of the following criteria:
- 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)
- Ovulation disorders defined as less than eight menstrual cycles per year
- Iodine allergy
- Male subfertility defined as a post-wash total motile sperm count < 3 x10^6 spermatozoa/ml
- Not willing or able to sign the consent form
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7926 |
| CCMO | NL62838.029.19 |
| OMON | NL-OMON52895 |