H2Oil-Timing
Research type
Research Study
Full title
Tubal flushing with oil-based contrast during HSG in subfertile women: Is early flushing effective and cost-effective as compared to delayed flushing?
IRAS ID
270125
Contact name
Anne P Hemingway
Contact email
Sponsor organisation
Amsterdam UMC, location Vrije Universiteit
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
, 20/LO/0608
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Infertility, defined as the inability to conceive within 1 year of unprotected intercourse, affects 1 out of 6 couples. The causes of infertility include disorders of ovulation, tubal pathology, uterine pathology, poor sperm quality and unexplained infertility, which represents a large fifth group.
Hysterosalpingography (HSG), a test to assess tubal patency and image the uterine cavity is commonly part of the fertility work-up offered to patients presenting with infertility. Debates about the therapeutic effects of tubal flushing during HSG started over six decades ago. Recent publications and randomised controlled trials (RCTs) have generated a worldwide-renewed interest in tubal flushing and the use of oil-based contrast for fertility enhancement.
This multi-centre, randomized controlled trial will assess whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and cost-effective compared to delayed tubal flushing 6 months after the completion of fertility work-up. The study looks to assess time to live birth in infertile women undergoing HSG, who 1) have a spontaneous menstrual cycle, 2) are at low risk for tubal pathology, 3) are under 39 years of age and 4) are undergoing fertility workup. These two time-points will be assessed to determine which timing of the HSG leads to shorter time to live birth and a shorter time to pregnancy. As we compare strategies that are already applied in current practice, no additional risks or burdens are expected from the study.
The primary outcome is time to live birth, calculated from positive pregnancy test and within 12 months after randomisation. The hypothesis is that the HSG during fertility work-up results in more pregnancies and a shorter time to pregnancy in comparison to delayed HSG, 6 months after fertility work-up. If women get pregnant sooner this will reduce the need for reproductive treatments and reduce medical costs.
REC name
London - Harrow Research Ethics Committee
REC reference
20/LO/0608
Date of REC Opinion
1 Jul 2020
REC opinion
Further Information Favourable Opinion