Unknown

Dataset Information

0

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.


ABSTRACT:

Background

The 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 design

Eligible 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).

Trial registration

[corrected] The trial has been assigned the following ISRCTN number: ISRCTN35859078.

SUBMITTER: El-Toukhy T 

PROVIDER: S-EPMC2795733 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

altmetric image

Publications

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.

El-Toukhy Tarek T   Campo Rudi R   Sunkara Sesh Kamal SK   Khalaf Yacoub Y   Coomarasamy Arri A  

Reproductive health 20091203


<h4>Background</h4>The 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 te  ...[more]

Similar Datasets

2015-12-31 | E-MTAB-2591 | biostudies-arrayexpress
2015-06-01 | GSE58144 | GEO
| S-EPMC27273 | biostudies-literature
| S-EPMC4726345 | biostudies-literature
| S-EPMC9389813 | biostudies-literature
2018-09-01 | GSE103465 | GEO
| S-EPMC8362597 | biostudies-literature
| S-EPMC2582115 | biostudies-other
2021-09-15 | GSE147442 | GEO
2011-01-22 | E-GEOD-26787 | biostudies-arrayexpress