Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04482751
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2020-07-03
Brief Title:
The Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa
Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Organization:
Azienda Ospedaliero-Universitaria di Modena
Study Overview
Official Title:
An Observational Single Center Study to Identify the Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa ACO Study
Status:
RECRUITING
Status Verified Date:
2023-02
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:
ACO
Brief Summary:
The objective of this study is to evaluate the trend of serum AMH during IVF in vitro fertilization cycles in particular the possible relationship between the dynamics of AMH and the early or normal response to therapies for controlled ovarian stimulation with corifollitropin alfa The secondary objective is to study the association between the number of follicles equal to or greater than 17 mm on the eighth day of ovarian stimulation and the decline in AMH and to assess the predictability of the need to add additional therapies after the first week of stimulation ovarian
Detailed Description:
The study is observational and it is monocentric and it will involve 80 patients Patients data extrapolated from the medical records of the Department of Reproductive Medicine in the Policlinico Hospital in Modena will be collected in an internal database for analysis The inclusion criteria for the population included in the study will be 1 basal serum FSH concentration below 20 UIL 2 age between 18 and 46 years 3 body weight 60 kg 4 use of corifollitrofin alpha for ovarian stimulation The following parameters will be evaluated the age of the patients their weight their body mass index BMI duration of infertility cycle characteristics basal day 2 AMH AFC measurement basal estradiol basal progesterone basal FSH basal LH and those same values on day 5 and day 8 of ovarian stimulation follicles 17 mm on day 8 type of gonadothropin further added days of stimulation with the further gonadothropin and its units per day AMH on trigger day and the number of oocytes retrieved The confidentiality of the informations will be guaranteed by anonymized data analysis All the data are commonly recorded in our clinical practice
The observed period will be of 12 months The date of conclusion of the study after favorable opinion of the Ethics Committee and the authorization of the Company Management is scheduled for June 2021
To guarantee the consent and the information of the patients involved in the study the Information Sheet and the relative Consent Form are attached We consider appropriate to inform the General Physician of the enlisted patients about the study the Information Letter for the General Physician is therefore attached
VariablesTime Points of Interest
The variables which will be recorded on cycle day 2 of a spontaneous menstruation stimulation day 1 with Corifollitropin alfa are womans age years weight kg body-mass-index kgm2 duration of infertility months cycle length in days by patient recall cycle regularity yesno deviation of 5 days from two consecutive cycles is considered an irregular cycle total number of antral follicles 2-10 mm in both ovaries AFC measured by a transvaginal scan and serum AMH ngml oestradiol progesterone FSH and LH
Patients will return every two days to the clinic for a transvaginal ultrasound from stimulation day 5 up to and including the day of hCG Serum hormone concentrations FSH LH oestradiol progesterone and AMH will be measured on stimulation days 5 and 8 and on the day of hCG
All hormones reported above will be measured in the central lab of the ospital as per routine practice Remaining serum will be used for the AMH assay The measurement of the AMH will ber profrmed in the ObGyn University research Lab
The observed period will be of 12 months The date of conclusion of the study after favorable opinion of the Ethics Committee and the authorization of the Company Management is scheduled for June 2021
To guarantee the consent and the information of the patients involved in the study the Information Sheet and the relative Consent Form are attached We consider appropriate to inform the General Physician of the enlisted patients about the study the Information Letter for the General Physician is therefore attached
VariablesTime Points of Interest
The variables which will be recorded on cycle day 2 of a spontaneous menstruation stimulation day 1 with Corifollitropin alfa are womans age years weight kg body-mass-index kgm2 duration of infertility months cycle length in days by patient recall cycle regularity yesno deviation of 5 days from two consecutive cycles is considered an irregular cycle total number of antral follicles 2-10 mm in both ovaries AFC measured by a transvaginal scan and serum AMH ngml oestradiol progesterone FSH and LH
Patients will return every two days to the clinic for a transvaginal ultrasound from stimulation day 5 up to and including the day of hCG Serum hormone concentrations FSH LH oestradiol progesterone and AMH will be measured on stimulation days 5 and 8 and on the day of hCG
All hormones reported above will be measured in the central lab of the ospital as per routine practice Remaining serum will be used for the AMH assay The measurement of the AMH will ber profrmed in the ObGyn University research Lab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None