We hypothesize that the fertility enhancing effect of OSCM during HSGs is also present during THL.
ID
Source
Brief title
Condition
- Ovarian and fallopian tube disorders
Health condition
50 subfertile women who showed tubal patency of at least one tube at THL.
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
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.
Secondary outcome
The secondary objectives are the number and nature of adverse events, the influence on the thyroid function of the mother and the off-spring, and the amount of oil contrast that is necessary per procedure. The ongoing pregnancy rate, live birth rate and the mode of conception (IVF vs non-IVF) will be compared to the results from a previous study (van Kessel et al.).
Background summary
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 Implementation of the use of OSCM, namely Lipiodol® Ultra Fluid, is limited as in many clinics HSG has been replaced by other first line tests for tubal pathology, including hysterosalpingocontrast/foam sonography (HyCoSy/HyFoSy) and THL.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.
Study objective
We hypothesize that the fertility enhancing effect of OSCM during HSGs is also present during THL.
Study design
Baseline, 4 weeks, 6 months (in case of pregnancy within 6 months after delivery)
Intervention
Age
Inclusion criteria
- Age > 18 years - Subfertility, defined as lack of conception despite 12 months of unprotected intercourse - Tubal patency of at least one Fallopian tube
Exclusion criteria
- 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.
Design
Recruitment
IPD sharing statement
Postbus 7777
5500 MB Veldhoven
040 888 9528
metc@mmc.nl
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 | NL8696 |
| CCMO | NL67021.015.19 |
| OMON | NL-OMON49816 |