Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01887652
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2013-06-24
Brief Title:
Individualization of Ovarian Stimulation Using AMH Maximizes the Benefits and Minimizes Complications and Risks
Sponsor:
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Organization:
ANDROFERT - Clinica de Andrologia e Reproducao Humana
Study Overview
Official Title:
Individualization of Controlled Ovarian Stimulation Using Anti-mullerian Hormone as a Biomarker of Ovarian Response Maximizes the Beneficial Effects of Treatment and Minimizes Complications and Risks
Status:
COMPLETED
Status Verified Date:
2014-06
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:
None
Brief Summary:
The purpose oh the study is to determine the usefulness of anti-Mullerian hormone AMH to identify women at risk of excessive and poor response in controlled ovarian stimulation COS for in vitro fertilization IVF and the clinical impact of applying individualized COS strategies in these subsets of patients
Detailed Description:
A group of 130 women undergoing conventional COS after pituitary down-regulation for IVF will be studied to determine the best cut-off points of AMH using receiver operating characteristic ROC analysis to discriminate excessive 20 oocytes retrieved and poor response 4 oocytes retrieved The inclusion criteria is any patient with indication of IVF treatment Subsequently a different group of 120 women with the same criteria will be assessed using AMH before starting COS and treatment strategy will be individualized according to AMH results iCOS Mild stimulation using daily doses 1125 to 150 IU of recombinant follicle stimulation hormone rec-hFSH or rec-hFSH combined with recombinant luteinizing hormone LH supplementation 375 IU total daily dose will be given to patients identified as at risk of excessive and poor response respectively It will evaluated number of oocytes clinical pregnancy rates defined as fetal heartbeat on ultrasound performed 4 weeks after the transfer of embryos and occurrence of Ovarian hyperstimulation syndrome Outcomes will be compared between the groups who received conventional and iCOS using chi-square and Fisher exact tests
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