TRial of OutPatient HYsteroscopy in in-vitro fertilisation (IVF)

ISRCTN	ISRCTN35859078
DOI	https://doi.org/10.1186/ISRCTN35859078
Secondary identifying numbers	0102

Submission date: 05/02/2009
Registration date: 06/02/2009
Last edited: 05/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tarek El-Toukhy
Scientific

Assisted Conception Unit
11th Floor, Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 0497
Email	tarek.el-toukhy@gstt.nhs.uk

Study information

Study design	Randomised single-blind controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	Trophy in IVF
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2009
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	756
Key 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.
Key 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
Date of first enrolment	01/07/2009
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guy's Hospital

London
SE1 9RT
United Kingdom

Sponsor information

Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Department
Conybeare House
Guy's Hospital
St. Thomas Street
London
SE1 9RT
England
United Kingdom

Phone	+44 (0)20 8188 5736
Email	karen.ignatian@gstt.nhs.uk
Website	http://www.guysandstthomas.nhs.uk/
"ROR"	https://ror.org/00j161312

Funders

Funder type

Government

Guy's and St Thomas' NHS Foundation Trust (UK) - Assisted Conception Unit

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	03/12/2009		Yes	No
Results article	results	25/06/2016		Yes	No

Editorial Notes

05/05/2016: Publication reference added.