Subjects at increased risk of ovarian hyperstimulation syndrome (OHSS).
Conditions
Interventions
Trade Name: GONAL-f 900 IU/1.5 ml
Product Name: GONAL-f
Pharmaceutical Form: Solution for injection
Sponsors
Helsingin Lääkärikeskus Oy, Graviditas Lapsettomuusklinikka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Indication for in vitro fertilisation treatment (IVF) 2. Increased risk of moderate or severe ovarian hyperstimulation syndrome (OHSS) because of polycystic ovary (PCO) or multifollicular ovary (MFO) (ten or more antral follicles in one ovary seen in transvaginal ultrasound (TVU) or because of symptoms or signs of an increased risk of moderate or severe OHSS in previous ovarian stimulations 3. Women aged 18-38 4. Subject is willing and able to participate in the trial and has signed an informed consent form before undergoing any study related activities Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy; 2. History of current disease or concomitant medication known to harm IVF treatment or subsequent pregnancy; 3. More than three previous IVF cycles without conception; 4. BMI >30 kg/m2; 5. Subject’s partner has a severe sperm damage (sperm count 12IU/l; LH 496 mIU/l) 16. Any other condition, circumstance or previous medication that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether ovarian hyperstimulation syndrome (OHSS) can be avoided with the delayed start of r-hFSH in ovarian stimulation for IVF treatment in subjects at increased risk of OHSS.;Secondary Objective: To study the ability to achieve a reasonable number of ongoing pregnancies with the planned study medication in this trial. ;Primary end point(s): The proportion of subjects without moderate or severe OHSS (defined by classification adapted from RCOG Green-Top Guideline no 5, 2006) (1). - Clinical pregnancy rate - Defined by positive pregnancy test (human chorionic gonadotropin (hCG), determined from urinary or serum sample) 14 days after embryo transfer and by presence of a gestational sac assessed by transvaginal ultrasound examination 5 weeks (± 1 week) after embryo transfer. - Number of cycle cancellations (defined as withholding of hCG injection) - Number of subjects with transferable embryos. - Number of subjects having frozen embryos - Severity of OHSS (none, mild, moderate, severe) - Adverse events - Pregnancy outcome up to 12 pregnancy weeks (Oocyte retrieval day = end of the second pregnancy week) | — |
Countries
Finland
Outcome results
None listed