Contact information
Type
Scientific
Primary contact
Dr Tarek El-Toukhy
ORCID ID
Contact details
Assisted Conception Unit
11th Floor
Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0)20 7188 0497
tarek.el-toukhy@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0102
Study information
Scientific title
A multicentre randomised controlled study of the effects of outpatient hysteroscopy on the outcome of the subsequent in-vitro fertilisation (IVF) cycle after recurrent IVF failure
Acronym
Trophy in IVF
Study hypothesis
A recent systematic review suggested the outcome of in-vitro fertilisation (IVF) treatment could be improved in patients who have experienced recurrent IVF failure if an outpatient hysteroscopy (OH) is performed prior to starting the new treatment cycle. The review recommended performing a randomised trial to settle this research question. Therefore, this trial proposes 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 2 - 4 previous failed IVF cycles.
Ethics approval
Not provided at time of registration
Study design
Randomised single-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Recurrent in-vitro fertilisation (IVF) failure
Intervention
The trial participants are randomised to one of two regimens:
1. Out-patient hysteroscopy in the follicular phase (days 5 - 14) of the menstrual cycle where the IVF cycle is due to start, followed by standard IVF treatment (according to local standard IVF protocol with or without the use of intracytoplasmic sperm injection
2. Standard IVF treatment (as above) without a prior out-patient hysteroscopy
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Live birth event per cycle started, measured after 9 months of embryo transfer.
Secondary outcome measures
1. Embryo implantation rate
2. Pregnancy rate per IVF cycle started
3. Clinical pregnancy rate per IVF cycle started
4. Miscarriage rate per pregnancy achieved
Measured 2 and 4 weeks after embryo transfer.
Overall trial start date
01/07/2009
Overall trial end date
30/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women undergoing an IVF (with or without intracytoplasmic sperm injection) treatment cycle who have had between 2 - 4 failed previous fresh IVF attempts ending in an embryo transfer
2. Aged 36 years or less
3. Willing and able to give informed consent
Women who have had a previous hysteroscopy will be included.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
756
Participant exclusion criteria
1. Women who had less than 2 or more than 4 failed fresh IVF attempts ending in an embryo transfer
2. Women aged more than 36 years (i.e. women aged 37 years or more)
3. Presence of submucous or intramural uterine fibroids distorting the uterine cavity or untreated tubal hydrosalpinges
Recruitment start date
01/07/2009
Recruitment end date
30/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
Conybeare House
Guy's Hospital
St. Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 8188 5736
karen.ignatian@gstt.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St Thomas' NHS Foundation Trust (UK) - Assisted Conception Unit
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19958545
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27132053
Publication citations
-
Protocol
El-Toukhy T, Campo R, Sunkara SK, Khalaf Y, Coomarasamy A, A multi-centre randomised controlled study of pre-IVF outpatient hysteroscopy in women with recurrent IVF implantation failure: Trial of Outpatient Hysteroscopy - [TROPHY] in IVF., Reprod Health, 2009, 6, 20, doi: 10.1186/1742-4755-6-20.
-
Results
El-Toukhy T, Campo R, Khalaf Y, Tabanelli C, Gianaroli L, Gordts SS, Gordts S, Mestdagh G, Mardesic T, Voboril J, Marchino GL, Benedetto C, Al-Shawaf T, Sabatini L, Seed PT, Gergolet M, Grimbizis G, Harb H, Coomarasamy A, Hysteroscopy in recurrent in-vitro fertilisation failure (TROPHY): a multicentre, randomised controlled trial, Lancet, 2016, pii: S0140-6736(16)00258-0, doi: 10.1016/S0140-6736(16)00258-0.