Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2026-03-07 @ 2:07 PM
Study NCT ID:
NCT02269306
Status:
COMPLETED
Last Update Posted:
2014-10-21
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
Sponsor:
Menoufia Obstetrics and Gynecology Group
Organization:
Study Overview
Official Title:
Visceral Fat Area and Other Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2014-10
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:
The purpose of this study is to determine whether Visceral fat area and other criteria assessed during initial screening could predict the response to ovulation induction with clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).
Detailed Description:
The study was carried out on 150 patients with PCOS. Initial CC doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end point.Statistical methods Distribution of characteristics in patients is presented as the mean ± SD. We used the Mann-Whitney U test for exploratory comparison of initial parameters between responders and nonresponders. The univariate and multivariate relation with response to CC was assessed using logistic regression analysis. Backward stepwise elimination was used for the multivariate logistic analysis of prediction of patients being CRA, and P \< 0.10 was used as a cut-off level for elimination of non-significant predictors from the prognostic model. The area under the receiver operating characteristics (ROC) curve (AUC) was used to assess the discriminative ability of the logistic models. SPSS with statistical package version 17 (SPSS Inc., Chicago, IL) and MedCalc Software version 12.4, (Ostend, Belgium) were employed for data analysis.
Study Oversight
Has Oversight DMC:
True
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?: