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RESEARCH QUESTION/RATIONALE

We recently showed that in infertile women oil-based contrast during HSG resulted in 10% higher 6-month ongoing pregnancy rates than the use of water-based contrast. As this study was limited to ovulatory women at low risk for tubal pathology under the age of 39, it is unclear whether this strong fertility enhancing effect is also present in other groups of infertile women. We therefore will assess this treatment in women who

1: have ovulation disorders;

2: are at high risk for tubal pathology;

3: are >38 years of age?

 

HYPOTHESIS

We hypothesize that

• tubal flushing at HSG with oil-based contrast will result in more live births than HSG with the use of water-based contrast in women

1. with a ovulation disorder

2. at high risk for tubal pathology

3. > 38 years of age

• the use of oil-based contrast in these subgroups of infertile women is cost-effective compared to the use of water-based contrast.

 

STUDY DESIGN

Multi-center randomized controlled trial with an economic analysis alongside it.

 

STUDY POPULATION

We will study women

1: with ovulation disorders (defined as less than 8 menstrual cycles per year) or;

2: at high risk for tubal pathology (defined as positive Chlamydia Antibody Test, chlamydia infection, pelvic

inflammatory disease, abdominal surgery and/or peritonitis in the medical history) or;

3: women >38 years of age

 

INTERVENTION & COMPARATOR

We will compare tubal flushing with oil contrast (intervention) versus tubal flushing with water-contrast (control).

 

OUTCOME MEASURES

Primary outcome is conception leading to live birth within 6 months after randomization.

 

SAMPLE SIZE/DATA-ANALYSIS

A total of 930 participants (310 in every subgroup) is needed to demonstrate a difference of =10% in live birth rate over a control rate of 17% (power 80%, alpha 0.05, 15% loss to follow up). Under the assumption that the three subgroups have an equal distribution, it allows for adequate power to study the 10% difference in each subgroup.

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