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.
ID
Bron
Verkorte titel
Aandoening
Subfertility, tubal patency testing
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Ongoing pregnancy defined as registered heartbeat on ultrasound beyond 12 weeks of gestation within the first 6 months after randomisation.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
6 months post hysterosalpingography.
Onderzoeksproduct en/of interventie
Tubal flushing with oil based contrast medium versus water based contrast medium.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3120 |
| NTR-old | NTR3270 |
| CCMO | NL26044.018.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON32658 |