Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502281
Status:
SUSPENDED
Last Update Posted:
2013-04-09
First Post:
2007-07-12
Brief Title:
Controlled Ovarian Stimulation Followed by Timed Intercourse or Intrauterine Insemination in Infertile PCOS Patients
Sponsor:
University Magna Graecia
Organization:
University Magna Graecia
Study Overview
Official Title:
Timed Intercourse Versus Intrauterine Insemination in Infertile Patients Undergoing Gonadotropin Ovarian Stimulation
Status:
SUSPENDED
Status Verified Date:
2013-04
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:
At the present the first options to induce ovulation in polycystic ovary syndrome with anovulatory infertility are clomiphene citrate CC and metformin Notwithstanding the effectiveness of CC and metformin alone or in a sequential or combined regimen a percentage of patients ranging from 5 to 30 remain anovulatory For these patients the use of gonadotropins for controlled ovarian stimulation COS is indicated
Moreover to date it isnt clear if COS should be followed by timed intercourse TI or intrauterine insemination IUI
The aim of the present study will be to compare TI and IUI in infertile PCOS patients undergoing COS in terms of cost-benefit
Moreover to date it isnt clear if COS should be followed by timed intercourse TI or intrauterine insemination IUI
The aim of the present study will be to compare TI and IUI in infertile PCOS patients undergoing COS in terms of cost-benefit
Detailed Description:
Infertile PCOS patients who remain anovulatory after CC or metformin treatment will be enrolled All patients will receive gonadotropins in low-dose step-up protocol for COS and randomized to receive three trials of TI group A or IUI group B
All patients eligible will undergo baseline assessment consisting of anthropometric hormonal and ultrasonographic evaluations
In all patients the COS will be obtained using highly purified urinary FSH in a low-dose step-up protocol and both TI and IUI will be performed after 35 hours from ovulation induction with human chorionic gonadotropin
During the study the clinical and reproductive outcomes the adverse experience will be evaluated in each patient
Data will be analyzed using the intention-to-treat principle and a P value of 005 or less will be considered significant Continuous variables will be analyzed with the unpaired t test and general linear model for repeated measures analysis with Bonferroni test for the post-hoc analysis as required For categorical variables the Pearson chi-square and Fishers exact tests will be used Cumulative pregnancy rate our primary end-point will be calculated by the Kaplan-Maier method and the differences between the two groups will be assessed with the log-rank test Cox proportional-hazards model will be used to calculate the hazard ratio for new pregnancy in both groups
All patients eligible will undergo baseline assessment consisting of anthropometric hormonal and ultrasonographic evaluations
In all patients the COS will be obtained using highly purified urinary FSH in a low-dose step-up protocol and both TI and IUI will be performed after 35 hours from ovulation induction with human chorionic gonadotropin
During the study the clinical and reproductive outcomes the adverse experience will be evaluated in each patient
Data will be analyzed using the intention-to-treat principle and a P value of 005 or less will be considered significant Continuous variables will be analyzed with the unpaired t test and general linear model for repeated measures analysis with Bonferroni test for the post-hoc analysis as required For categorical variables the Pearson chi-square and Fishers exact tests will be used Cumulative pregnancy rate our primary end-point will be calculated by the Kaplan-Maier method and the differences between the two groups will be assessed with the log-rank test Cox proportional-hazards model will be used to calculate the hazard ratio for new pregnancy in both groups
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