Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220545
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2005-09-14
Brief Title:
Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
A Prospective Randomized Controlled Trial to Compare Laparoscopic Ovarian Diathermy With Clomiphene Citrate as a First Line Treatment of Anovulatory Infertility in Patients With Polycystic Ovarian Syndrome
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Laparoscopic ovarian diathermy LOD is currently offered to infertile women with polycystic ovarian syndrome PCOS who fail to conceive on clomiphene citrate CC However using LOD before CC may result in a better reproductive outcome since LOD may reduce risks associated with CC such as miscarriages and multiple pregnancies The aim of the study is to evaluate the effectiveness of LOD and its potential value in improving the success rates in infertile women with PCOS This study will recruit 72 women with PCOS suffering from infertility due to lack of ovulation from the infertility clinic After initial assessment patients will be given explanation about the study and will receive an information leaflet They will then be randomized into two groups Group1 36 patients will receive CC as per infertility clinic protocol to induce ovulation for up to 6 months Group 2 36 patients will undergo laparoscopic ovarian diathermy under general anaesthetic Blood samples will be taken from both groups before any treatment shortly after treatment and at 3 and 6 months after treatment to measure various hormones Patients will be contacted every month after treatment for follow up The reproductive outcomes particularly the pregnancy and livebirth rates will be compared between the two groups
Detailed Description:
None
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