TRial of OutPatient HYsteroscopy in in-vitro fertilisation (IVF)
| ISRCTN | ISRCTN35859078 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35859078 |
| Protocol serial number | 0102 |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (UK) |
| Funder | Guy's and St Thomas' NHS Foundation Trust (UK) - Assisted Conception Unit |
- 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
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 |
|---|---|
| tarek.el-toukhy@gstt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Live birth event per cycle started, measured after 9 months of embryo transfer. |
| Key secondary outcome measure(s) |
1. Embryo implantation rate |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/06/2016 | Yes | No | |
| Protocol article | protocol | 03/12/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/05/2016: Publication reference added.
