Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378729
Status:
UNKNOWN
Last Update Posted:
2011-10-04
First Post:
2006-09-19
Brief Title:
Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome PCOS
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
PERCING Ovarian Drilling Versus Ovarian Stimulation Intra Uterine Insemination IUI Metformin in the PCOS PolyCystic Ovaries Syndrome Treatment
Status:
UNKNOWN
Status Verified Date:
2007-10
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:
PERCING
Brief Summary:
PolysCsytic Ovaries Syndrome PCOS is the most frequent endocrinopathy The first stage of infertility treatment is Clomiphene Citrate which leads to 50 pregnancies In case of failure it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination IUI which lead to 50 pregnancies each However surgical treatment could be associated to surgical complications and medical treatment could be associated to ovarian hyperstimulation syndrome andor multiple pregnancies
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments After an ambulatory surgery we will observe the spontaneous fertility during 9 months For the medical treatment Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments After an ambulatory surgery we will observe the spontaneous fertility during 9 months For the medical treatment Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal
Detailed Description:
PolysCsytic Ovaries Syndrome PCOS is the most frequent endocrinopathy The first stage of infertility treatment is Clomiphene Citrate which leads to 50 pregnancies In case of failure it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination IUI which lead to 50 pregnancies each However surgical treatment could be associated to surgical complications and medical treatment could be associated to ovarian hyperstimulation syndrome andor multiple pregnancies
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments After an ambulatory surgery we will observe the spontaneous fertility during 9 months For the medical treatment Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal Ovarian drilling will be performed by FERTILOSCOPY 126 patients will be necessary in each group with interval of equivalence 10
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments After an ambulatory surgery we will observe the spontaneous fertility during 9 months For the medical treatment Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal Ovarian drilling will be performed by FERTILOSCOPY 126 patients will be necessary in each group with interval of equivalence 10
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