The objective of this study is to assess the costs and effects of two strategiesof tubaI testing during the fertility work-up, one based on the new technique hysterosalpingo-foam sonography (HyFoSy) (innovative strategy) and the other on…
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy rates leading to live birth within 12-months after
inclusion.
Secondary outcome
- Time to pregnancy
- Clinical pregnancy rate
- Miscarriage rate
- Multiple pregnancy rate
- Preterm birth rate
- Concordance between HyFoSy and HSG
- Sensitivity and specificity of HyFoSy and HSG
- Procedure time of tubal patency test
- Direct and indirect costs
- Preference and pain scores
Background summary
HSG is the most widely used outpatient tubal test during fertility vvork-up. lt
was introduced in 1914 and still serves as an accurate diagnostic test, but
it is a painful examination, implies exposure to ionizing radiation and is
expensive. lf HyFoSy appears to be as accurate as HSG in diagnosing tubal
patency with subsequent equal management decisions and pregnancy outcomes as
a HSG-based strategy of tubal testing, HSG could be substituted by HyFoSy
during fertility vvork-up. Given the fact that approximately 20.000 HSGs are
performed each year in the Netherlands and based on a cost difference between
HyFoSy and HSG of ¤100, replacing HSG by HyFoSy would result in a health care
cost reduction of ¤2 million annually.
Study objective
The objective of this study is to assess the costs and effects of two
strategiesof tubaI testing during the fertility work-up, one based on the new
technique hysterosalpingo-foam sonography (HyFoSy) (innovative strategy) and
the other on hysterosalpingography (HSG)(conventional strategy).
Study design
This is a multicenter prospective study with two embedded RCTs. (Bossuyt et
al., 2000). We plan that 1163 women scheduled tor tubal testing during their
fertility work-up wilI be included in the study.AII wilI undergo both a HyFoSy
and a HSG in random order (RCT 1). Women in whom the results of the tubaI
patency tests (HyFoSy/HSG) show discordance will subsequently be randomised in
a second RCT (RCT2) for management based on the results of HSG or management
based on the resuts of HyFoSy. If bilateral occlusion is found by the allocated
tubal patency test, management will be a diagnostic laparoscopy with
chromopertubation (DLS). In case of unilateral or bilateral patent tubes are
found by the allocated tubal patency test, management according to the
prognostic model of Hunault will be applied. This means no subsequent invasive
diagnostic interventions, but a prognosis (on natural conception) guided
management. (Hunault et al.,2005)
Intervention
Hysterosalpingo-foam sonography (HyFoSy) and hysterosalpingography (HSG). In
case of dicordant test results women will be randomised for a management
strategy based on HyFoSy or HSG. If bilateral occlusion is found by the
allocated tubal patency test, the subsequent management will be DLS. In case
unilateral or bilateral patency is found by the allocated tubal patency test,
the subsequent management will be according to the prognostic model of Hunault.
Study burden and risks
Known complications of HSG are pain related to the procedure, risk of post
procedural infection and allergic reaction on iodine. Intravasation of contrast
can also result in allergic reactions. If intravasation of contrast medium is
detected the procedure will immediately be abandoned. No complications or
potential risks after a HyFoSy procedure are reported up till now.
In case a women will be randomised for a laparoscopy, risks are related to
anaesthesia and surgical intervention (bleeding, infection, pain and viseral
damage).
De Boelelaan 1118
Amsterdam 1081HZ
NL
De Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
- Women between 18-41 years
- Subfertile for at least one year.
- Valid indication for patency testing in the fertility work-up or before
intra-uterine insemination treatment.
Exclusion criteria
- Anovulation not responding on ovulation induction
- Endometriosis
- Severe male factor with a Total motile sperm count <1x106/ml
- Known contrast (iodine) allergy
- If not willing or able to sign the informed consent
Design
Recruitment
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 |
|---|---|
| CCMO | NL50484.029.14 |
| OMON | NL-OMON28335 |