Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02013973
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2013-12-06
Brief Title:
Predictive Value of AMH in IVF a Prospective RCT
Sponsor:
Ann Thurin Kjellberg
Organization:
Sahlgrenska University Hospital Sweden
Study Overview
Official Title:
Predictive Value of AMH AMHAnti Müllerian Hormone in IVF IVFIn Vitro Fertilization a Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMH
Brief Summary:
The primary aim of this trial is to compare two groups of women undergoing IVF IVFin vitro fertilisation treatment to investigate if assessment of AMH AMHAnti-Müllerian hormone in addition to assessment of maternal age AFC AFCantral follicle count and BMI BMIbody mass index gives a more optimal COH COHcontrolled ovarian stimulation than does assessment of only age AFC and BMI measured as number of patients obtaining 5-12 oocytes during COH
Detailed Description:
At the first visit to the IVF-clinic a CRF CRFCase Report Form of demographics will be filled in regarding age BMI parity presence of PCOS PCOSpolycystic 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 pmoll 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 rFSHrecombinat 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 pmoll the dose is reduced with one step according to the dose algorithm If estradiol is 350 pmoll 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 IUinternational units rHCG rHCGrecombinant 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 GQEgood 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 OHSSovarian 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
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 rFSHrecombinat 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 pmoll the dose is reduced with one step according to the dose algorithm If estradiol is 350 pmoll 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 IUinternational units rHCG rHCGrecombinant 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 GQEgood 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 OHSSovarian 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None