Abstract
BackgroundThe success rate of IVF treatment is low. A recent systematic review and meta-analysis found that the outcome of IVF treatment could be improved in patients who have experienced recurrent implantation failure if an outpatient hysteroscopy (OH) is performed before starting the new treatment cycle. However, the trials were of variable quality, leading to a call for a large and high-quality randomised trial. This protocol describes a multi-centre randomised controlled trial to test the hypothesis that performing an OH prior to starting an IVF cycle improves the live birth rate of the subsequent IVF cycle in women who have experienced two to four failed IVF cycles.Methods and designEligible and consenting women will be randomised to either OH or no OH using an internet based trial management programme that ensures allocation concealment and employs minimisation for important stratification variables including age, body mass index, basal follicle stimulating hormone level and number of previous failed IVF cycles. The primary outcome is live birth rate per IVF cycle started. Other outcomes include implantation, clinical pregnancy and miscarriage rates.The sample size for this study has been estimated as 758 participants with 379 participants in each arm. Interim analysis will be conducted by an independent Data Monitoring Committee (DMC), and final analysis will be by intention to treat. A favourable ethical opinion has been obtained (REC reference: 09/H0804/32).Trail RegistrationThe trial has been assigned the following ISRCTN number: ISRCTN35859078
Highlights
The success rate of in vitro fertilization (IVF) treatment is low
One of the common investigations proposed after recurrent IVF failure is outpatient hysteroscopy (OH)
Routine OH prior to IVF has been suggested by a number of investigators to ensure normality of the uterine cavity before embryo transfer [12,13,14,15,16,17,18,19] this proposition has not been tested in a randomised setting
Summary
Objective In the proposed trial we will evaluate whether performing an OH prior to starting an IVF cycle improves the likelihood of achieving a live birth after the IVF cycle in women who have experienced two to four IVF implantation failures. Inclusion criteria Women undergoing an IVF (with or without intracytoplasmic sperm injection) treatment cycle who have had between two to four fresh IVF cycles ending in an embryo transfer but no implantation are eligible to participate in the trial. Exclusion criteria Women who had less than two or more than four failed fresh IVF cycles ending in an embryo transfer, women aged 37 years or more at the time of randomisation, women who have had a hysteroscopy within 2 months of randomisation, the presence of submucous or intramural uterine fibroids distorting the uterine cavity or untreated tubal hydrosalpinges and a body mass index (BMI) above 35 (36 or higher). Women randomised to OH arm will attend the respective Unit for OH within 14 days of the beginning of menstruation They will be expected to start the IVF process according to a standard controlled ovarian stimulation protocol [24].
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