An interventional study of clomiphen citrate in Anovulation, sponsored by Menoufia Obstetrics and Gynecology Group. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-10-21.
Sponsored by Menoufia Obstetrics and Gynecology Group · Not applicable and Interventional
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).
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.
The study included 150 infertile women(age from 18 to 40 years) with PCOS diagnosed by the presence of at least two of the following [15]:
Exclusion Criteria:
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.
Drug: clomiphen citrate
The study was carried out on 150 patients with PCOS. Initial clomiphen citrate (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.
Also known as: clomid
ovulation
Time frame: 3 months ( cycles)
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Menoufia Obstetrics and Gynecology Group