Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A prospective randomised sibling-oocyte study of two sequential media for culturing cleavage stage embryos
Acronym
Study hypothesis
Commercially available culture media are expected to be equally efficient in fertilisation and culture of early embryos.
Ethics approval
Local ethics committee (Örebro läns landsting) (Sweden) gave approval on the 25th March 2003 (ref: 90/03)
Study design
Prospective randomised single centre single-blinded (patients only) sibling study
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
Infertility
Intervention
The study included two commercially available sequential media for fertilisation and culture of oocytes. One of the media system was standard in our clinic, while the other media system was standard in the private clinic in our town. It was not expected that there would be a difference.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Fertilisation rate, measured at 1 day
2. Polynuclei rate, measured at 2 days
3. Cleavage rate, measured at 2 days
Secondary outcome measures
1. Positive human chorionic gonadotrophin (hCG) rate, measured at 1 - 2 weeks.
2. Clinical pregnancy rate, measured at 12 weeks
3. Implantation rate, measured at 12 weeks
4. Delivery rate, measured at 9 months
Overall trial start date
01/10/2007
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
All oocytes from patients (aged 24 - 40 years, female) undergoing in vitro fertilisation (IVF) treatment
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
110 patients/1200 oocytes
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/10/2007
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Women's and Children's Health
Uppsala
751 85
Sweden
Sponsor information
Organisation
Uppsala County Council (Uppsala Läns Landsting) (Sweden)
Sponsor details
Kvinno och Barndivisionen
Akademiska sjukhuset
Uppsala
751 85
Sweden
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Uppsala University Hospital (Sweden) - Centre of Reproduction
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