Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461643
Status:
UNKNOWN
Last Update Posted:
2013-04-09
First Post:
2007-04-13
Brief Title:
Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS
Sponsor:
University Magna Graecia
Organization:
University Magna Graecia
Study Overview
Official Title:
Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome a Multicentre Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2013-04
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:
Anovulatory infertility is a common feature of the polycystic ovary syndrome PCOS Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients very few data are available in literature regarding the best integrated strategy In fact a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy
The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate
The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate
Detailed Description:
All patients eligible will undergo baseline assessment consisting of antropometric hormonal and ultrasonographic assessments Successively patients enrolled will be allocated in three different strategies strategy A B and C
A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies clomiphene followed by clomiphene plus metformin followed by gonadotropins strategy A metformin followed by metformin plus clomiphene followed by gonadotropinsstrategy B and metformin plus clomiphene followed by gonadotropinsstrategy C
In all patients the same regimen will be used to administered clomiphene metformin and gonadotropinsBoth clomiphene and metformin will be administered at incremental doses in each caseGonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol
During the study the clinical and reproductive outcomes and adverse experiences will be evaluated in each woman
A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies clomiphene followed by clomiphene plus metformin followed by gonadotropins strategy A metformin followed by metformin plus clomiphene followed by gonadotropinsstrategy B and metformin plus clomiphene followed by gonadotropinsstrategy C
In all patients the same regimen will be used to administered clomiphene metformin and gonadotropinsBoth clomiphene and metformin will be administered at incremental doses in each caseGonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol
During the study the clinical and reproductive outcomes and adverse experiences will be evaluated in each woman
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