Condition category
Pregnancy and Childbirth
Date applied
05/02/2009
Date assigned
06/02/2009
Last edited
05/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.guysandstthomas.nhs.uk/

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

Results - basic reporting

Publication summary

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19958545
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27132053

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes

05/05/2016: Publication reference added.