Objectives: The purpose of this study is to assess the costs and effects of THL compared to HSG in a large randomized controlled trial.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The primary outcome is cumulative live birth
rate at 24 months.
Secondary outcome
Secondary outcomes are time to live birth, pregnancy outcome (on-going
pregnancy, miscarriage, multiple pregnancy), complications, diagnostic
accuracy, generic quality of life, pain and discomfort, patient preferences and
costs.
Background summary
Rationale: Infertility or involuntary childlessness is one of life*s great
misfortunes that affects approximately one in ten couples that aim for
conception. Together with poor semen quality and anovulation, tubal pathology
ranks among the most frequent causes of subfertility. From the 15,000 couples
presenting with subfertility each year, approximately 3,000 will have tubal
pathology.
To diagnose tubal pathology various diagnostic tests are available.
Hysterosalpingography (HSG) and diagnostic laparoscopy are established invasive
tests. Recently, transvaginal hydrolaparoscopy (THL) was developed. THL has the
advantage of direct visualisation of the tubes, but in contrast to diagnostic
laparoscopy, the procedure can be performed in an outpatient setting.
Although THL seems promising, it is unclear what its effectiveness and costs
are relative to the current best imaging strategy, HSG.
Study objective
Objectives: The purpose of this study is to assess the costs and effects of THL
compared to HSG in a large randomized controlled trial.
Study design
Study design: Multicenter randomized controlled clinical trial.
Intervention
Intervention: Women will be randomly allocated to THL or HSG.
Study burden and risks
As we compare strategies that are already applied in current practice, no
additional risks or burdens are expected from the study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Women presenting with primary or secondary subfertility for at least 12 months
* Age >18 years
* Normal transvaginal ultrasound, performed in the follicular phase of the menstrual cycle
* Presence of both ovaries
Exclusion criteria
* Positive Chlamydia status at PCR
* Prior tubal testing
* Immobile uterus not allowing THL
* Women with a uterus in retroversion flexion, as a THL is not feasible in these women
* Masses/or cysts in the pouch of Douglas or ovarian cysts, interfering with THL
* Prior tubal surgery
* Iodine allergy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41088.018.12 |