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

NCT ID: NCT02269306

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Anovulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

clomiphen citrate(cc)

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.

Group Type: EXPERIMENTAL

clomiphen citrate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

clomid

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Menoufia Obstetrics and Gynecology Group

OTHER

Sponsor Role: lead

Responsible Party

Dr Hamed Ellakwa

Dr Hamed Ellakwa

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hamed El Ellakwa, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufiya faculty of medicine,menoufiya university,ministry of higher education

Locations

Menoufia University hospital

Shebin Elkom, Menoufia, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 26848057 (View on PubMed)

Other Identifiers

Menoufia OGG-1

Identifier Type: -

Identifier Source: org_study_id