Ignite Creation Date:
2024-05-06 @ 12:50 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01662180
Status:
UNKNOWN
Last Update Posted:
2012-12-13
First Post:
2012-07-26
Brief Title:
Predicting Ovarian Response in Artificial Insemination With Low Stimulation
Sponsor:
Isala
Organization:
Isala
Study Overview
Official Title:
Predicting Ovarian Response in Artificial Insemination With Low Stimulation
Status:
UNKNOWN
Status Verified Date:
2012-12
Last Known Status:
RECRUITING
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:
This large prospective multi-center cohort study aims to identify patients characteristics that significantly influence ovarian response to mild stimulation with a fixed dose of 75 IU recombinant FSH
Detailed Description:
A multi-center open-label prospective cohorts study Patients with a regular indication for COHIUI controlled ovarian stimulation intra uterine insemination will be asked to participate Patients characteristics will be documented including age weight BMI smoking status cycle day 2 3 or 4 FSH Estradiol levels antral follicle count and AMH AMH and FSHEstradiol will be determined centrally after completion of inclusion of all patients in the study All patients will receive a fixed 75 IU recFSH per day conform normal stimulation protocol starting from cycle day 3 4 or 5 after exclusion of ovarian cysts by ultrasound Ovarian response will be documented by ultrasound only Once the dominant follicles reach a mean diameter of 16-18 mm hCG 5000IU or 250 mcg will be applied and insemination will be scheduled 36-42 hours later Cancellation criteria will be defined according to the national guidelines provided by the NVOG 7
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