|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Comparison of day 5 and day 6 embryo transfers for slow growing embryos for in vitro fertilisation (IVF) treatment |
| ISRCTN | ISRCTN90191687 |
| DOI | 10.1186/ISRCTN90191687 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Comparison of day 5 and day 6 embryo transfers for slow growing embryos for in vitro fertilisation (IVF) treatment |
| Scientific title | When is the best time to replace slow developing embryos? A comparison between day 5 and day 6 transfers: A randomised controlled trial |
| Acronym | N/A |
| Serial number at source | FE1203 |
| Study hypothesis | Embryo implantation involves the complex interplay between the receptivity of the womb lining and embryo quality. The developmental potential of slower developing embryos is similar to faster developing ones as shown by similar outcomes for frozen embryos replaced in frozen embryo replacement cycles (Shapiro et al). However embryos with a faster developmental pace transferred on day 5 in a fresh cycle give an advantage in terms of clinical pregnancy rate over slower developing embryos transferred on day 6 (Shapiro et al). This suggests that delayed fresh transfers may have a suboptimal outcome due to embryo-endometrial asynchrony. The dilemma arises if there are no fast developing embryos for transfer seen on day 5. There have been no randomised control trials which would point to the best timing for replacement of slow embryos in these women. Would it be correct to transfer the best available embryos on day 5, or replace embryos on day 6 after delayed culture? |
| Lay summary |
Background and study aims
Literature confirms that fast developing blastocysts [blastocyst is a highly differentiated, highly developed embryo that has grown to the point where it is ready to attach to the uterine wall (implantation)] transferred on day 5 are associated with good pregnancy rates. The dilemma arises if there are no fast developing expanded blastocysts for transfer seen on day 5. What is the optimal time for transfer of these embryos? Would it be correct to transfer the best available less expanded embryos on day 5 or replace delayed blastocysts on day 6? There have been no studies to compare the implantation potential of slow developing day 5 blastocysts transferred on day 5 with those transferred on day 6. The objective of this study is to ascertain if differences exist in pregnancy outcomes in the two groups both with slow developing embryos on day 5: transfer of fresh day 5 slow developing embryos compared to transfer of day 6 fully developed blastocysts transferred on day 6. Who can participate? Women aged 21-45 undergoing In vitro fertilisation (IVF) / Intra-cytoplasmic sperm injection ( ICSI) treatment and reaching a day 5 embryo transfer but with no fast developing blastocysts on day 5 will be eligible to participate in the study. Women who have already participated in the study for a previous cycle will be excluded. What does the study involve? Recruited participants will be randomised into two groups. They will either have an embryo transfer on day 5 or extended embryo culture and embryo transfer on day 6. What are the possible benefits and risks of participating? The participant may benefit from an improved pregnancy rate if randomised to an arm which is later found to be superior to the other arm. Embryo transfer is a part of routine treatment. The research protocol will only change the time of the embryo transfer. Hence there will be no additional risks or burdens of the research for the participant. Where is the study run from? The study will be carried out in a tertiary referral teaching university fertility unit. When is the study starting and how long is it expected to run for? We aim to start the study by Feb 2013 and it is expected to last between 12-18 months. Who is funding the study? The study is sponsored by the Homerton University Hospital NHS Foundation Trust. Who is the main contact? Dr Priya Bhide, Associate Specialist, Homerton University Hospital priya.bhide@homerton.nhs.uk |
| Ethics approval | Not provided at time of registration |
| Study design | Pilot randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Subfertility patients undergoing IVF / ICSI treatment |
| Participants - inclusion criteria |
Women age 21-45 undergoing a single IVF / Intra-cytoplasmic sperm injection (ICSI) treatment with their own oocytes during the specified study duration who:
1. Proceed to have a day 5 transfer 2. Have no fast developing embryos for transfer on day 5 |
| Participants - exclusion criteria | Women who have already participated in the study for a previous cycle |
| Anticipated start date | 01/02/2013 |
| Anticipated end date | 01/02/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact Dr Priya Bhide (priya.bhide@homerton.nhs.uk) to request a patient information sheet |
| Target number of participants | 100 |
| Interventions |
All participants will follow the routine IVF / ICSI protocol till the day of embryo transfer. Following this they will be allocated to either of the two study arms.
Study arm 1: patient to have embryo transfer on day 5 Study arm 2: patient to have extended embryo culture and transfer of embryos on day 6 Following embryo transfer all participants will again follow routine clinical care protocols standard to IVF. |
| Primary outcome measure(s) | Clinical pregnancy rate |
| Secondary outcome measure(s) | Delayed blastocyst conversion rate |
| Sources of funding | Homerton University Hospital NHS Foundation Trust (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Roy Homburg |
| Address |
Homerton Fertility Centre
Homerton Row |
| City/town | London |
| Zip/Postcode | E9 6SR |
| Country | United Kingdom |
| Sponsor | Homerton University Hospital NHS Foundation Trust (UK) |
| Address |
Homerton Hospital
Homerton Row |
| City/town | London |
| Zip/Postcode | E9 6SR |
| Country | United Kingdom |
| Sponsor website: | http://www.homerton.nhs.uk/ |
| Date applied | 27/11/2012 |
| Last edited | 27/12/2012 |
| Date ISRCTN assigned | 27/12/2012 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
