Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome

Anovulation Clinical Trial

Official title:

Visceral Fat Area and Other Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269306
• Other study ID #: Menoufia OGG-1
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: October 16, 2014
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2014
• Source: Menoufia Obstetrics and Gynecology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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]:

1. Clinical hyperandrogenism: Hirsutism or acne vulgaris and/or biochemical hyperandrogenism (total testosterone >88 ng/dl or DHEAS >275 ug/dL)[16]. (2) Menstrual and/or ovulatory disturbances, mainly oligomenorrhea (interval between vaginal bleeding >35 days and < 6 months) or amenorrhea (bleeding interval >6 months). (3) Polycystic ovaries as visualized by transvaginal ultrasound (either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume >10 cm3).

Exclusion Criteria:

• Patients having one or more of these criteria were excluded; Age <18 years or >40 years, body mass index (BMI) <18.5 kg/m2 or >35 kg/m2, pregnancy, endocrine disorders, systemic disease, current or previous (within the last 3 months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction or dopaminergic agents, use of antidiabetes, antiobesity drugs or history of tubal or ovarian surgery.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anovulation
• Polycystic Ovary Syndrome

Intervention

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.

Locations

Country	Name	City	State
Egypt	Menoufia University hospital	Shebin Elkom	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia Obstetrics and Gynecology Group

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovulation		3 months ( cycles)	Yes