The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is number of top embryos per ovum pick up.
Secondary outcome
Secondary outcome measures are duration of stimulation, cancellation rate,
fertilization rate, number of cumulus oocyte complexes obtained, number of
mature oocytes obtained, number of top embryos per started cycle, amount of IU
recFSH, implantation rates in high responders, endocrine changes (FSH,
Oestradiol, Progesteron, LH, AMH) and clinical pregnancy rate.
Background summary
Milder stimulation protocols have the advantage of being less expensive and
more patient-friendly. Moreover, recent evidence suggests that mild stimulation
protocols lead to lower embryo aneuploidy rates compared to conventional
treatment regimens. Although with mild stimulation protocols the expected
number of oocytes retrieved will be lower, pregnancy rates have shown to be
similar possibly because embryo quality outfavours embryo quantity.
Study objective
The aim of the study is to determine whether cycle day (CD) 5 start of
stimulation will lead to better quality of embryos, based on morphology, than
CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day.
Study design
Prospective randomized trial comparing two different starting days of
ovariumstimualtion (day 2 versus day 5) for IVF treatment.
Intervention
One group wil start on cycle day 2 with stimulation of the ovari with
recombinant FSH. The other group will start on cycle day 5. Both group will
start suppressing the gonadotrophin production of the the pituitary gland on
cycle day 6 with a GnRH antagonist.
Study burden and risks
Patients will visit the hospital for performing an ultrasound and blood
samples. This probably will be ones or twices more than during a standard IVF
treatment.
The risks will be comparable with the standard IVF treatment; risk of
infection, bleeding, or ovarium hyperstimulation syndrome. De side effects of
the medication are the same as in the standard IVF treatment.
Postbus 85500
3508 GA Utrecht
NL
Postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
Female age < 39 years
FSH < 12 IU/l
BMI 18-29 kg/m2
Regular cycle (25-35 days)
No major uterine or ovarian abnormalities
No previous IVF cycles
Written informed consent
Exclusion criteria
Oocyte donation
Medical contra indication for pregnancy or IVF treatment
Endometriosis >= grade 3
Polycystic Ovarium Syndrome (PCOS)
Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-005261-57-NL |
| CCMO | NL23705.041.08 |