In Vitro Maturation as part of the treatment of infertility in women with PolyCystic Ovaries. Is priming with hCG favourable? A prospective randomized study

ISRCTN	ISRCTN17078060
DOI	https://doi.org/10.1186/ISRCTN17078060
Protocol serial number	OUHIVMproj-1-pco-hcg
Sponsor	Odense University Hospital (Denmark)
Funders	Fertility Clinic, Department of Obstetrics and Gynaecology , Odense University Hospital (Denmark), University of Southern Denmark (Denmark), MediCult (manufacturer of laboratory IVM-medium) (Denmark)

Submission date: 27/03/2007
Registration date: 15/05/2007
Last edited: 10/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

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 Mikael Tang-Pedersen
Scientific

Fertility Clinic
Department of Obstetrics and Gynaecology
Odense University Hospital
Soendre Boulevard 29
Odense C
5000
Denmark

Phone	+45 6541 1572
Email	mikael.tang-pedersen@ouh.regionsyddanmark.dk

Study information

Primary study design	Interventional
Study design	Prospective open-label randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	IVM-PCO-project-OUH
Study objectives	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(s)	The scientific ethical commitee for the counties of Funen and Vejle, 11/04/2006, ref: VF 20050163
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	01/04/2006
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

Denmark

Study participating centre

Fertility Clinic

Odense C
5000
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan