Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
Information source: Menoufia Obstetrics and Gynecology Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anovulation
Intervention: clomiphen citrate (Drug)
Phase: N/A
Status: Completed
Sponsored by: Menoufia Obstetrics and Gynecology Group Official(s) and/or principal investigator(s): Hamed El Ellakwa, MD, Principal Investigator, Affiliation: Menoufiya faculty of medicine,menoufiya university,ministry of higher education
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).
Clinical Details
Official title: Visceral Fat Area and Other Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
Study design: Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: ovulation
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Menoufia University hospital, Shebin Elkom, Menoufia 11111, Egypt
Additional Information
Starting date: January 2011
Last updated: October 16, 2014
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