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 |
| Secondary identifying numbers | OUHIVMproj-1-pco-hcg |
- 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
Scientific
Fertility Clinic
Department of Obstetrics and Gynaecology
Odense University Hospital
Soendre Boulevard 29
Odense C
5000
Denmark
| Phone | +45 6541 1572 |
|---|---|
| mikael.tang-pedersen@ouh.regionsyddanmark.dk |
Study information
| Study design | Prospective open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/04/2006 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
5000
Denmark
Sponsor information
Odense University Hospital (Denmark)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof Lars G Westergaard
Fertility Clinic
Department of Obstetrics and Gynaecology
Odense University Hospital
Soendre Boulevard 29
Odense C
5000
Denmark
"ROR" |
https://ror.org/00ey0ed83 |
|---|
Funders
Funder type
Not defined
Fertility Clinic, Department of Obstetrics and Gynaecology , Odense University Hospital (Denmark)
No information available
University of Southern Denmark (Denmark)
No information available
MediCult (manufacturer of laboratory IVM-medium) (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
