Status:
COMPLETED
Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
Lead Sponsor:
Menoufia Obstetrics and Gynecology Group
Conditions:
Anovulation
Eligibility:
FEMALE
18-40 years
Phase:
NA
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) ...
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 dai...
Eligibility Criteria
Inclusion
- 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 \[15\]:
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02269306
Start Date
January 1 2011
End Date
January 1 2013
Last Update
October 21 2014
Active Locations (1)
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1
Menoufia University hospital
Shebin Elkom, Menoufia, Egypt, 11111