Luteal Phase Versus Follicular Phase Administration of Clomiphene Citrate in PCOS, A Randomized Controlled Trial

• Status: Unknown status
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams Maternity Hospital
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Medroxyprogesterone Acetate; Zuclomiphene

Criteria

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.