No registrations found.
ID
Source
Brief title
Health condition
Subfertility, tubal patency testing
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy defined as registered heartbeat on ultrasound beyond 12 weeks of gestation within the first 6 months after randomisation.
Secondary outcome
Clinical pregnancy, defined as an ultrasound visible gestational sac.
Miscarriage, defined as a spontaneous loss off pregnancy
Ectopic pregnancy, defined as an embryo implants outside the uterine cavity.
Pregnancy leading to live birth
Live birth, defined as the birth of at least one living child.
Pain scores after the procedure.
Cost calculations of OSCM / WSCM and assisted reproductive technology (ART) treatments.
Background summary
In the evaluation of female subfertility, hysterosalpingography (HSG) is an important examination because of its diagnostic value. The procedure delineates the uterine cavity contours and the rugation and the patency of the fallopian tubes. Since the introduction of HSG as a diagnostic test, various contrast media have been used, from water-soluble to oil-soluble, ionic to nonionic, and high osmolarity to low osmolarity.
A possible therapeutic effect of diagnostic tubal patency testing has been debated in the literature for more than 50 years.
There are some small studies that show that flushing with Oil-soluble contrast medium (OSCM) has a significant higher odds ratio of live birth compared to flushing with Water-soluble contrast medium (WSCM). But other small studies showed no significant different in odds ratio of pregnancy or live births after flushing during HSG examination with OSCM or WSCM.
The purpose of this multi centre, randomised controlled trial, is to determine whether at HSG the use of oil-based contrast media results in higher ongoing pregnancy and live birth rates compared to the use of water-based contrast media.
Study objective
The primary hypothesis is that flushing of the fallopian tubes is more effective with an oil based contrast medium compared to a water based contrast medium in terms of ongoing pregnancy.
Study design
6 months post hysterosalpingography.
Intervention
Tubal flushing with oil based contrast medium versus water based contrast medium.
VU University Medical Center<br>
PK 6Z K180<br>
De Boelelaan 1118
K. Dreyer
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4445277
k.dreyer@vumc.nl
VU University Medical Center<br>
PK 6Z K180<br>
De Boelelaan 1118
K. Dreyer
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4445277
k.dreyer@vumc.nl
Inclusion criteria
1. Age between 18 up to and including 39 years;
2. Subfertility of at least one year;
3. Chlamydia antibody titer (CAT) negative;
4. Low risk of tubal pathology according to the medical history;
5. Valid indication for HSG in the fertility work-up or before intra uterine insemination treatment.
Exclusion criteria
1. Endocrino-pathological diseases as: PCOS, Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type 1;
2. Known or high risk for tubal pathology, CAT positive;
3. Known contrast (iodine) allergy;
4. Male subfertility defined as a post-wash total motile sperm count < 3x10.6 spermatozoa/ml;
5. If not willing or able to sign the consent form.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3120 |
| NTR-old | NTR3270 |
| CCMO | NL26044.018.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON32658 |