To determine whether flushing of the fallopian tubes is more effective with an oil based contrast medium or a water based contrast medium in terms of ongoing pregnancy.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
ongoing pregnancy rates
Secondary outcome
live birth rate, miscarriages, ectopic pregnancy, pain score, coital frequency
before and after HSG, pregnancy leading to live birth.
Background summary
As stated by the authors of a Cochrane review from Luttjeboer et al 2007
*further robust randomized trials comparing oil-soluble versus water-soluble
media should be undertaken and would be a useful further guide to clinical
practice*. The aim of this study proposal is therefore to perform a large
multicentre randomized controlled trial of flushing with oil-soluble versus
water-soluble contrast media in women with a low a priory chance of tubal
pathology. The outcome measure is a ongoing pregnancy rate after six months.
Study objective
To determine whether flushing of the fallopian tubes is more effective with an
oil based contrast medium or a water based contrast medium in terms of ongoing
pregnancy.
Study design
Randomized clinical study
Intervention
Hysterosalpingography eighter with oil- or waterbased contrast media.
Study burden and risks
The potential benefit of OSCM would be increased probability of pregnancy. The
potential harm would be possible complications from the use of OSCM. As stated
in the protocol, the current randomised trials do not provide a clear answer to
this question.
meibergdreef 9
1105 DE Amsterdam
NL
meibergdreef 9
1105 DE Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* Age between 18 and 39 years
* Subfertility of at least one year
* Chlamydia Antibody Titre (CAT) negative (MIF <1:64 or ELISA <1:1)
* Low risk for tubal pathology according to the medical history (Coppus et al., 2007)
* Valid indication for HSG in the fertility work-up or before intra uterine insemination treatment.
Exclusion criteria
* Endocrino-pathological disease as: Polycystic ovary syndrome, Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I.
* Known or high risk for tubal pathology, CAT positive (MIF titre > 1:64 or ELISA > 1.1)
* Known contrast (iodine) allergy
* Male subfertility defined as a post-wash total motile sperm count < 3 x106 spermatozoa/ml
* If 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 | EUCTR2008-007878-38-NL |
| CCMO | NL26044.018.08 |
| OMON | NL-OMON23300 |