Contact information
Type
Scientific
Primary contact
Dr Mikael Tang-Pedersen
ORCID ID
Contact details
Fertility Clinic
Department of Obstetrics and Gynaecology
Odense University Hospital
Soendre Boulevard 29
Odense C
5000
Denmark
+45 6541 1572
mikael.tang-pedersen@ouh.regionsyddanmark.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
OUHIVMproj-1-pco-hcg
Study information
Scientific title
Acronym
IVM-PCO-project-OUH
Study hypothesis
Antral ovarial follicles are possibly sensitive for priming with hCG, due to expression of LH-receptors in granulosa cells. The in vitro maturation process might benefit from priming with hCG before aspiration of small follicles (<11 mm). The size of the follicles, measured by ultrasound scanning, and serum concentration of various hormones, will be related to the outcome of the treatment in each group (hCG vs no hCG).
Ethics approval
The scientific ethical commitee for the counties of Funen and Vejle, 11/04/2006, ref: VF 20050163
Study design
Prospective open-label randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Infertility and PCO.
Intervention
hCG-injection vs no injection 36 hours before aspiration of oocytes.
Randomization is performed by a nurse two days before aspiration of immature oocytes. Block randomization is used, at a size of 50 (25+25) patients.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Primary outcome measures amended as of 26/06/2007:
1. Maturation rate (number of mature [M2] oocytes per number of aspirated
oocytes) at 30 and 46 hours
2. Fertilization rate (number of fertilized oocytes per number of matured
oocytes) at 46 and 70 hours
Primary outcome measures provided at time of registration:
1. Maturation rate (number of mature [M2] oocytes per number of aspirated oocytes)
2. Fertilization rate (number of fertilized oocytes per number of matured oocytes)
Secondary outcome measures
Secondary outcome measures amended as of 26/06/2007:
1. Number of transferable embryos with normal development on day 2 after fertilization, as a fraction of aspirated, matured and fertilized oocytes in IVF and Intra Cytoplasmatic Sperm Injection (ICSI) groups
2. Maturation rate in relation to follicle size (46 hours after maturation)
3. Maturation rate in relation to serum concentrations of various hormones, measured on various cycle days and days of randomization and aspiration
Secondary outcome measures provided at time of registration:
1. Number of transferable embryos with normal development on day 2 after fertilization, as a fraction of aspirated, matured and fertilized oocytes in IVF and Intra Cytoplasmatic Sperm Injection (ICSI) groups
2. Maturation rate in relation to follicle size
3. Maturation rate in relation to serum concentrations of various hormones, measured on various cycle days and days of randomization and aspiration
Overall trial start date
01/04/2006
Overall trial end date
01/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women with PolyCystic Ovaries (PCO) according to Rotterdam criteria (2003)
2. Referred to the Fertility Clinic, Odense University Hospital
3. Candidates for IVF-treatment according to the standards of the Fertility Clinic
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. Normal ovarial morphology
2. Manifest diseases requiring medication e.g. diabetes mellitus
3. Endocrine diseases, e.g. hyperprolactinaemia, hyper-and hypothyroidism
4. Abuse of drugs or alcohol
5. More than two previous IVF treatments
Recruitment start date
01/04/2006
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Denmark
Trial participating centre
Fertility Clinic
Odense C
5000
Denmark
Funders
Funder type
Not defined
Funder name
Fertility Clinic, Department of Obstetrics and Gynaecology , Odense University Hospital (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Southern Denmark (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
MediCult (manufacturer of laboratory IVM-medium) (Denmark)
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