The main objective of this study is to determine whether tubal flushing with oil-based contrast during HSG results into more pregnancies leading to live births when compared to tubal flushing with ExEm-foam during HyFoSy, and whether this approach…
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is pregnancy leading to live birth within six months after
randomization. Pregnancy is defined as a positive pregnancy tests or a
pregnancy shown on ultrasonographic examination. Live birth is defined as the
birth of live baby born beyond 24 weeks of pregnancy.
Secondary outcome
- Time to pregnancy leading to live birth. Calculated from the day of
randomization till the first day of the last menstrual bleeding.
- Number of clinical pregnancies, miscarriages, ectopic pregnancies, multiple
pregnancies, still births. All within 6 months after randomization.
- Number of adverse events within one months after tubal patency testing, e.g.
infection, intravasation, thyroid dysfunction.
- Procedural pain scores, measured by Visual Analogue Scale (VAS) immediately
after tubal patency testing.
- Number of fertility treatment cycles (IUI, IVF, ICSI) within 6 months after
randomization.
- Number of pregnancy complications, e.g. pregnancy induced hypertension, fetal
growth restriction.
- Neonatal outcomes, e.g. date of birth, sexes, birth weight.
- Quality of life, using EQ-5D-5L questionnaire measured 6 months after
randomization.
- Cost-effectiveness, the effectiveness (pregnancies leading to live births)
compared to the costs (including costs from a healthcare perspective (costs for
tubal patency testing and fertility treatment) and costs from a societal
perspective using the iMedical Productivity Costs Questionnaire (iMPCQ)) for
both tubal flushing strategies.
Background summary
We hypothesize that tubal flushing with oil-based contrast during HGS leads to
more live births compared to tubal flushing with ExEm-Foam during HyFoSy in
infertile women with indication for tubal patency testing. If more live births
are achieved, expensive fertility treatments will be less needed, which makes
tubal flushing with oil-based contrast during HSG a cost-effective strategy.
Study objective
The main objective of this study is to determine whether tubal flushing with
oil-based contrast during HSG results into more pregnancies leading to live
births when compared to tubal flushing with ExEm-foam during HyFoSy, and
whether this approach is cost-effective. In this study we will also compare the
safety of both strategies.
Study design
We plan a multicenter randomized controlled trial with an economic analysis
alongside it. Women with indication for tubal patency testing will be
randomized to tubal flushing with oil-based contrast during HSG and tubal
flushing with ExEm Foam during HyFoSy.
Study burden and risks
As we compare two tubal flushing strategies (tubal flushing with oil-based
contrast during HSG and tubal flushing with ExEm-foam during HyFoSy) that are
already applied in current practice, no additional risks or burdens are
expected from the study. Women are asked to fill in three to five
questionnaires. One questionnaire to measure quality of life at baseline (day
of randomization) and six months after randomization. One questionnaire to
measure indirect (from a societal perspective) costs six months after
randomization. Follow-up data can be obtained by a follow-up questionnaire six
months after randomization and if applicable two months post-partum, if these
data is not reported in their medical files.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Infertile women or women with oligo-or anovulation
- Aged between 18 and 42 years
- With indication for tubal patency testing during the fertility work-up
- Sufficient understanding of the Dutch or English language
- Signed informed consent
Exclusion criteria
- Severe male factor with a total motile sperm count <3x106ml (pre-washed) -
Known contrast (iodine) allergy - Women who have had a gynecologic procedure
within the last 30 days - Women with known or suspected reproductive tract
neoplasia
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 | NL83352.018.22 |