PCOS Clinical Trial
Official title:
Luteal Phase Versus Follicular Phase Administration of Clomiphene Citrate in PCOS, A Randomized Controlled Trial
INTRODUCTION Polycystic ovary syndrome (PCOS) is one of the most common female endocrine
disorders (Fauser et al., 2011). It is a complex, heterogeneous disorder of uncertain
aetiology, but there is strong evidence that it can, to a large degree, be classified as a
genetic disease (Fauser et al., 2011). Genetic and environmental contributors to hormonal
disturbances combine with other factors, including obesity (Diamanti-Kandarakis et al.,
2006). Ovarian dysfunction and hypothalamic pituitary abnormalities contribute to the
etiology of PCOS (Doi et al., 2005).
It produces symptoms in approximately 5% to 10% of women of reproductive age (12-45 years
old). It is thought to be one of the leading causes of female subfertility (Goldenberg and
Glueck, 2008).
Its prevalence has increased with the use of different diagnostic criteria and has recently
been shown to be 18% (17.8 ± 2.8%) in the first community-based prevalence study based on
current Rotterdam diagnostic criteria (March et al., 2010).
AIM OF THE WORK The study will compare the luteal phase (early) administration of clomiphene
citrate to the conventional (late) administration of the same drug in the follicular phase
as regards ovarian response in PCOS.
Research Question What is the difference between administration of clomiphene citrate in the
luteal phase and the follicular phase for ovulation induction in women with PCOS? Research
Hypothesis Luteal phase administration of clomiphene citrate protocol gives better results
than conventional administration of clomiphene citrate in the follicular phase as regards
ovarian response in PCOS.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | July 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: A. Women aged 20-40 years old. B. Patients with diagnosis of PCOS based on the 2003 ESHRE/ASRM (Rotterdam) criteria: to include two of the following, in addition to exclusion of related disorders: 1. Oligo / anovulation 2. Hyperandrogenism and/or Hyperandrogenemia 3. Polycystic ovaries by U/S i.e. at least one ovary showing either 1 - 12 more follicles (2-9 mm in diameter) or ovarian volume > 10 mm. Exclusion Criteria: A. Age < 20 or > 40. B. Major pelvic pathology. C. Ovarian masses. D. Infertility due to causes other than ovarian factors e.g. 1. Bilateral tubal block 2. Congenital anomaly of the uterus 3. Male factor of infertility E. Liver disease F. Other endocrinopathies e.g. hyperprolactinemia, Lipoid Congenital Adrenal Hyperplasia (LCAH), hypothyroidism, hyperthyroidism and Cushing's disease. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams Maternity Hospital | Cairo | |
Egypt | Ain Shams Maternity Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams Maternity Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the total number of follicles, number of follicles > 14 mm in diameter, number of follicles > 18 mm in diameter. | the total number of follicles, number of follicles > 14 mm in diameter, number of follicles > 18 mm in diameter. | 6 months | No |
Secondary | endometrial thickness | endometrial thickness | 6 months | No |
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