Comparison between two commercially available embryo culture media

ISRCTN ISRCTN24759945
DOI https://doi.org/10.1186/ISRCTN24759945
Secondary identifying numbers N/A
Submission date
03/02/2009
Registration date
13/03/2009
Last edited
13/03/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anneli Stavreus-Evers
Scientific

Department of Women's and Children's Health
Uppsala University Hospital
Uppsala
751 85
Sweden

Study information

Study designProspective randomised single centre single-blinded (patients only) sibling study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA prospective randomised sibling-oocyte study of two sequential media for culturing cleavage stage embryos
Study objectivesCommercially available culture media are expected to be equally efficient in fertilisation and culture of early embryos.
Ethics approval(s)Local ethics committee (Örebro läns landsting) (Sweden) gave approval on the 25th March 2003 (ref: 90/03)
Health condition(s) or problem(s) studiedInfertility
InterventionThe 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 typeOther
Primary outcome measure1. Fertilisation rate, measured at 1 day
2. Polynuclei rate, measured at 2 days
3. Cleavage rate, measured at 2 days
Secondary outcome measures1. 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 study start date01/10/2007
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants110 patients/1200 oocytes
Key inclusion criteriaAll oocytes from patients (aged 24 - 40 years, female) undergoing in vitro fertilisation (IVF) treatment
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/10/2007
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Sweden

Study participating centre

Department of Women's and Children's Health
Uppsala
751 85
Sweden

Sponsor information

Uppsala County Council (Uppsala Läns Landsting) (Sweden)
Government

Kvinno och Barndivisionen
Akademiska sjukhuset
Uppsala
751 85
Sweden

Website http://www.lul.se/
ROR logo "ROR" https://ror.org/01dv86r63

Funders

Funder type

Hospital/treatment centre

Uppsala University Hospital (Sweden) - Centre of Reproduction

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan