Condition category
Pregnancy and Childbirth
Date applied
27/03/2007
Date assigned
15/05/2007
Last edited
10/10/2014
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 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

Sponsor information

Organisation

Odense University Hospital (Denmark)

Sponsor details

c/o Prof Lars G Westergaard
Fertility Clinic
Department of Obstetrics and Gynaecology
Odense University Hospital
Soendre Boulevard 29
Odense C
5000
Denmark

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes