Clinical trial NCT02269306: Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
Official title: Visceral Fat Area and Other Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anovulation
Keywords: PCOS
clomiphene citrate
AMH
visceral fat area
HOMA-IR
Lead sponsor: Menoufia Obstetrics and Gynecology Group
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility 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.

Primary outcomes:
measure: ovulation
timeFrame: 3 months ( cycles)
Secondary outcomes:
Other outcomes:
Locations:
city: Shebin Elkom
country: Egypt
facility: Menoufia University hospital
state: Menoufia
Study officials:
affiliation: Menoufiya faculty of medicine,menoufiya university,ministry of higher education
name: Hamed El Ellakwa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellakwa HE, Sanad ZF, Hamza HA, Emara MA, Elsayed MA. Predictors of patient responses to ovulation induction with clomiphene citrate in patients with polycystic ovary syndrome experiencing infertility. Int J Gynaecol Obstet. 2016 Apr;133(1):59-63. doi: 10.1016/j.ijgo.2015.09.008. Epub 2015 Dec 17.