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

NCT02024984 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-03-11

No results posted yet for this study

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.

Conditions

  • PCOS

Interventions

DRUG

Clomiphene Citrate

Group A (study group) 'Luteal Clomid': will include 45 patients to whom 100 mg of CC will be administrated daily for five days starting the next day after finishing MPA (medroxyprogesterone acetate) 10 mg tablet for five days, for one menstrual cycle, then a wash out period for another menstrual cycle, then the group treatment plan is shifted to administration of 100 mg of CC daily for five days starting on day 2 of the cycle induced by MPA for another menstrual cycle. Group B (control group)'Follicular Clomid': will include 45 patients to whom 100 mg of CC will be administrated daily for five days starting on day 2 of the cycle induced by MPA, for one menstrual cycle, then a wash out period for another menstrual cycle, then the group treatment plan is shifted to administration of 100 mg of CC daily for five days starting the next day after finishing MPA (medroxyprogesterone acetate) 10 mg tablet for five days for another menstrual cycle.

Sponsors & Collaborators

  • Ain Shams Maternity Hospital

    lead OTHER

Principal Investigators

  • Mohammed AA ALI, MBBCH · Resident Doctor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02024984 on ClinicalTrials.gov