Live Birth After Additional Tubal Flushing With Oil-based Contrast Versus no Additional Flushing:
Status:
Recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
Ten to 15 percent of couples in their reproductive lifetime face fertility problems which is
defined by WHO as the absence of pregnancy after minimal 12 months of unprotected sexual
intercourse. The three most frequent causes of subfertility are: sperm defects, ovulation
disorders and tubal pathology. In order to exclude tubal pathology, tubal patency tests are
performed under ultrasound guidance with foam (hysterosalpingo-foam sonography (Hyfosy)) or
with contrast/water (hysterosalpingo-contrast sonography (Hycosy)).
This trial will investigate whether tubal flushing with an oil-soluble contrast medium (OSCM)
can increase the likelihood of a spontaneous conception after tubal patency testing with
Hyfosy under ultrasound guidance compared to no additional flushing in a population of
infertile women between 18 and 40 years of age with absence of pregnancy after 12 months of
unprotected sexual intercourse or who have three cycles of donor insemination without
pregnancy or three ovulatory ovulation induction cycles without pregnancy. The use of
Lipiodol Ultra Fluide® is off-label in Hyfosy.
This multicenter, randomised, open-label, comparative and pragmatic trial compares 2 arms
which will be randomised 1:1:
- Intervention group: Tubal flush with 5-10mL oil-soluble contrast medium (Lipiodol Ultra
Fluide®, Guerbet, France) immediately after Hyfosy
- Control group: No additional intervention after Hyfosy The study comprises a screening
period of maximum 8 weeks (w-8 to d1), randomisation (w-8 to d1), a start study visit at
which the Hyfosy is performed (d1) and a fertility treatment period of 6 months
(d1-w26). If the woman is not pregnant at 6 months after Hyfosy, the follow-up will last
till 12 months (w52). If the participant is pregnant at 6 months after Hyfosy, the
follow-up will last till maximal 4 months after live birth or miscarriage.
The primary endpoint is the occurrence of live birth, with the first day of the last
menstrual cycle in which the patient conceives within 6 months after Hyfosy. Secondary
endpoints consist of reproductive outcomes, gestational age at delivery, birth weight,
neonatal mortality, major congenital anomaly, neonatal outcomes and thyroid function,
pregnancy complications, number of complications during or immediately after the
intervention, pain score of the Hyfosy and additional flush, thyroid function of the mother,
general and disease-specific quality of life.