We hypothesize that the fertility enhancing effect of OSCM during HSGs is also present during THL.
ID
Bron
Verkorte titel
Aandoening
- Ovarium- en eileideraandoeningen
Aandoening
50 subfertile women who showed tubal patency of at least one tube at THL.
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Overige
Uitkomstmaten
Primaire uitkomstmaten
The primary objective of this pilot study is to determine the feasibility of additional flushing of the fallopian tubes with Lipiodol Ultra Fluid, in terms of; the appearance of the oil at the tubal fimbriae, the appearance of mucus debris from the tubal fimbriae and the pain and acceptability scores of the patients.
Achtergrond van het onderzoek
Subfertility is one of life’s great misfortunes. 10-15% of couples seek specialist fertility care at least once during their reproductive lifetime. The three most frequent causes of subfertility are sperm defects, ovulation disorders, and tubal pathology. Over the last decade, transvaginal hydrolaparoscopy (THL) has been introduced as the method of the first choice for tubal testing in the fertility workup in four teaching hospitals in the Netherlands. However, THL denies a possible treatment effect of oil-soluble contrast media (OSCM). Such a treatment effect of hysterosalpingography (HSG) with OSCM has been debated since 1965, until a recent large randomised controlled trial (RCT) showed that HSG with OSCM resulted in higher live birth rates. Implementation of the use of OSCM, namely Lipiodol® Ultra Fluid, is limited as in many clinics HSG has been replaced by other first line tests for tubal pathology, including hysterosalpingocontrast/foam sonography (HyCoSy/HyFoSy) and THL. The feasibility of additional tubal flushing with Lipiodol® Ultra Fluid after tests such as THL is however still unclear.
Doel van het onderzoek
We hypothesize that the fertility enhancing effect of OSCM during HSGs is also present during THL.
Onderzoeksopzet
Baseline, 4 weeks, 6 months (in case of pregnancy within 6 months after delivery)
Onderzoeksproduct en/of interventie
After tubal patency has been established, women will undergo flushing of the fallopian tubes with OSCM additionally to the regular water-based methylene-blue tubal flushing at the THL.
Publiek
Wetenschappelijk
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age > 18 years - Subfertility, defined as lack of conception despite 12 months of unprotected intercourse - Tubal patency of at least one Fallopian tube
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Pregnancy - Chlamydia-infection, an acute pelvic inflammation - Immobile uterus not allowing THL - Women with an 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 - Iodine allergy - Allergy for methylene blue or oil containing contrast - Manifest thyroid dysfunction - Patients with traumatic injuries, recent major haemorrhage or bleeding (not including the menstruation) - The use of the following medicinal products: beta blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, interleukin II (IV route) - Male subfertility defined as a post-wash total motile sperm count < 3 million spermatozoa/mL - Not willing or able to sign the consent form.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Postbus 7777
5500 MB Veldhoven
040 888 9528
metc@mmc.nl
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| Register | ID |
|---|---|
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| CCMO | NL67021.015.19 |
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