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…
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is time to life birth within 6 and 12 months after
randomization. Time to live birth within 6 months after randomization provides
us information about the comparison on HSG with oil-based contrast performed
during fertility work-up compared to no HSG. Time to live birth within 12
months after randomization provides information on the comparison of HSG with
oil-based contract during fertility work-up versus 6 months after completing
fertility work-up. 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.
Secondary outcome
- Life birth
- Clinical pregnancy
- Ongoing pregnancy
- Miscarriage
- Ectopic pregnancy
- Multiple pregnancy
- Complications following HSG (infection, intravastion)
- 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)
- Direct and indirect costs within 12 months after randomization
- Thyroid function of neonate (determined by heelprick by RIVM)
- Level of pain and anxiety during HSG
Background summary
Staying childless, due to the inability to conceive, is one of life*s great
misfortunes. Infertility, defined as the inability to conceive within 1 year of
unprotected intercourse, affects 1 out of 6 couples trying to get pregnant. The
causes of infertility can be classified as anovulation, poor sperm quality and
tubal pathology, with unexplained infertility as a large fourth segment.
Fertility work-up generally includes an assessment of the (ovulatory) cycle, a
semen analysis and an tubal patency test. This evaluation of the tubes can be
done by several different tests, including a diagnostic laparoscopy, a
hysterosalphingo-foam sonography or a hysterosalpingography (HSG). An HSG is
the most widely used outpatient method for tubal patency testing during the
fertility work-up.
Although HSG was introduced as a diagnostic test, it has been hypothesized for
decades that tubal flushing at HSG in general, and specifically with oil
contrast, directly increases pregnancy rates. However, the evidence for this
fertility enhancement effect was lacking due to limited power of available
studies. Therefore, our group completed a large randomized clinical trial
(H2Oil study) comparing oil contrast or water contrast in infertile women
undergoing HSG. This landmark study showed that tubal flushing with oil
contrast resulted in a higher 6-month ongoing pregnancy rates than tubal
flushing with water contrast (39.7% versus 29.1%) (RR 1.37, 95%CI 1.16-1.61)
(Dreyer et al., 2017). The subsequent live-birth rate was also significantly
higher.
Our findings have fueled the debate about the timing of HSG with oil-based
contrast in the basic fertility work-up. One issue is that in our H2Oil trial
the median duration of infertility of participating couples was 20 months. It
is, however, unclear whether direct tubal flushing (preferably at 12 months
unfulfilled child wish) with oil contrast work-up is beneficial. Direct tubal
flushing with oil contrast as part of the fertility work-up might result in a
shorter time to pregnancy compared to delayed tubal flushing 6 months after
completion of fertility work-up.
Study 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.
Intervention
Direct tubal flushing with oil-based contrast as part of the fertility work-up
compared to delayed tubal flushing 6 months after the fertility work-up is
completed.
Study burden and risks
As we compare strategies (tubal flushing at HSG with oil-based contrast
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.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Women between 18-39 years of age
- Spontaneous menstrual cycle
- Perceived low risk for tubal pathology
- Undergoing fertility work-up with an indication for tubal patency testing
Exclusion criteria
- Women with known endocrine disorders (e.g. the polycystic ovary syndrome,
diabetes, hyperthyroidism and hyperprolactinemia, except for well managed
hypothyroidism (TSH 0.3-2.5mIU/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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-004153-24-NL |
| CCMO | NL62838.029.19 |
| Other | NTR NL7926 |
| OMON | NL-OMON23111 |