H2Oil2 Study
Research type
Research Study
Full title
Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial
IRAS ID
270603
Contact name
Anne P Hemingway
Contact email
Sponsor organisation
Amsterdam UMC, location Vrije Universiteit
Clinicaltrials.gov Identifier
20/LO/0607,
Duration of Study in the UK
4 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 is a multi-centre, randomized controlled trial with a recruitment target of 930 participants internationally. The purpose of this study is to assess the effectiveness and cost-effectiveness of the use of oil versus water-based contrast medium in terms of live birth in women undergoing HSG, who 1) have ovulation disorders, or 2) are at high risk for tubal pathology, or 3) are above 38 years of age. The study compares two types of contrast agents that can be used during tubal flushing at HSG with oil-based contrast (intervention) versus tubal flushing with water-based contrast (control). It is to investigate which type of contrast during the HSG leads to the highest chance of 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 conception leading to live birth, with a positive pregnancy test preceding the pregnancy within 6 months after randomization. We will also study time-to-pregnancy. The hypothesis is that HSG with oil-based contrast will increase pregnancy rates (and time to event (pregnancy)) and thus reduce the need for ART and reduce costs.
REC name
London - Harrow Research Ethics Committee
REC reference
20/LO/0607
Date of REC Opinion
1 Jul 2020
REC opinion
Further Information Favourable Opinion