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

Completed

Conditions: Infertility and PCO.
Pregnancy and Childbirth
Infertility and polycystic ovaries

Registration Number: ISRCTN17078060

Lead Sponsor: Odense University Hospital (Denmark)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 200

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures amended as of 26/06/2007:<br>1. Maturation rate (number of mature [M2] oocytes per number of aspirated <br>oocytes) at 30 and 46 hours <br>2. Fertilization rate (number of fertilized oocytes per number of matured <br>oocytes) at 46 and 70 hours<br><br>Primary outcome measures provided at time of registration:<br>1. Maturation rate (number of mature [M2] oocytes per number of aspirated oocytes) <br>2. Fertilization rate (number of fertilized oocytes per number of matured oocytes)

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures amended as of 26/06/2007: <br>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<br>2. Maturation rate in relation to follicle size (46 hours after maturation) <br>3. Maturation rate in relation to serum concentrations of various hormones, measured on various cycle days and days of randomization and aspiration<br><br>Secondary outcome measures provided at time of registration: <br>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<br>2. Maturation rate in relation to follicle size<br>3. Maturation rate in relation to serum concentrations of various hormones, measured on various cycle days and days of randomization and aspiration