Infertility Clinical Trial
Official title:
Predictive Value of AMH (AMH=Anti Müllerian Hormone ) in IVF (IVF=In Vitro Fertilization ); a Prospective Randomized Controlled Trial
The primary aim of this trial is to compare two groups of women undergoing IVF (IVF=in vitro fertilisation ) treatment, to investigate if assessment of AMH (AMH=Anti-Müllerian hormone ), in addition to assessment of maternal age, AFC (AFC=antral follicle count ) and BMI (BMI=body mass index ) gives a more optimal COH (COH=controlled ovarian stimulation than does assessment of only age, AFC and BMI, measured as number of patients obtaining 5-12 oocytes during COH.
At the first visit to the IVF-clinic a CRF (CRF=Case Report Form) of demographics will be
filled in regarding age, BMI, parity, presence of PCOS (PCOS=polycystic ovarian syndrome ),
smoking and duration of infertility and a blood sample for serum-AMH is taken and frozen for
later analysis. The serum-AMH level is constant during the menstrual period (La Marca et al
2006) and a blood sample can be taken on any cycle day. The AMH assay used is the Beckman
Coulter AMH Gene II assay. Classification of the serum AMH values into expected low-,
normal-, or high ovarian response is based on the data presented a large prospective cohort
study of patients going through COH (Nelson et al 2009). Since that publication used an
older assay the reference intervals are calculated and translated as described in a recent
publication on AMH assays (Nelson et al 2012). Serum-AMH level increases during GnRH (GnRH=
gonadotropin releasing hormone) agonist downregulation (Jayaprakasan et al 2008), thus the
blood sample is preferably taken before start of down-regulation. A long GnRH agonist
treatment protocol is used. Patients are down-regulated with GnRH agonist from luteal phase,
or first cycle day when anovulatory patient, until estradiol is < 200 pmol/l. After
down-regulation, an assessment of AFC will be performed by sonography, and the patient will
be randomized.
For the patients randomized to the AMH-group calculation of gonadotropin starting dose will
be made from an algorithm including age, BMI, AFC and serum-AMH. For the patients randomized
to the non-AMH-group, calculation of gonadotropin starting dose will be made from an
algorithm including only age, BMI and AFC. The AMH blood sample in this group will be
analyzed after completion of the study.
Stimulation is started with a dose of rFSH (rFSH=recombinat follicle stimulating hormone)
calculated according to the dose algorithms used in the two groups. The name of the
gonadotropin preparation, the dose and number of treatment days will be recorded. The same
applies for all drugs used. Monitoring will be performed with mandatory estradiol on the day
of stimulation start and on stimulation day 6. The dose of gonodotropin can be adjusted on
day 7. If estradiol is > 1200 pmol/l the dose is reduced with one step according to the dose
algorithm. If estradiol is < 350 pmol/l the dose is increased with one step according to the
dose algorithm. Vaginal sonography is performed on stimulation day 9-11 to estimate the
number and size of follicles. The number of follicles >10 mm at sonography 0-2 days before
ovulation induction is recorded. Ovulation induction with 6500 IU (IU=international units)
rHCG (rHCG=recombinant human chorion gonadotropin ) is given when >=2 follicles >=17 mm. 36
hours after ovulation induction transvaginal oocyte pickup is performed according to
standard procedure at the clinic using sedation and paracervical administration of local
anaesthetics, and all follicles > 10 mm are punctured. The oocytes will be fertilized using
standard IVF procedure. In the case of an unexpected poor semen sample on the day of ovum
pick-up microinjection will be performed. The fertilization rate is recorded. Embryo
transfer is done on day 2 or 3 according to routine procedures in the clinic. In the case of
no GQE (GQE=good quality embryos ) it is allowed to perform double embryo transfer,
otherwise single embryo transfer is mandatory. Luteal phase support using vaginal route is
given from the day of embryo transfer and for 14 more days, until pregnancy test (urinary ).
In case of impending OHSS (OHSS=ovarian hyperstimulation syndrome ), where decision is made
to cryopreserve all embryos, the outcome of the first transfer of a cryopreserved embryo
will be included in the study results for secondary endpoints. In case of pregnancy, an
early vaginal sonography is performed in pregnancy week 7-8. The number of cancelled cycles
due to poor response is recorded. The number of patients having moderate or severe OHSS,
requiring intervention, will be recorded until four weeks after ovum pick up.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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