Condition category
Urological and Genital Diseases
Date applied
03/02/2009
Date assigned
13/03/2009
Last edited
13/03/2009
Prospective/Retrospective
Retrospectively 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 Anneli Stavreus-Evers

ORCID ID

Contact details

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

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

http://www.lul.se/

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

Publication citations

Additional files

Editorial Notes