Light Dependence Of Reproductive Function In Women (M-s4) - Study Recruiting Patients

Main Category: Fertility
Also Included In: Women's Health / Gynecology;  Clinical Trials / Drug Trials
Article Date: 07 May 2007 - 11:00 PDT

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The study investigate a relationship between the menstrual cycle and the hours of sunshine available over year. A follicle growth/ovulation depending of the season (winter vs. summer) and seasonal trait (healthy women vs. (sub-)SAD women) is to be studied.

Condition
Healthy
Seasonal Affective Disorder

Intervention
Procedure: Light therapy

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study
Number of arms in study: 2

Total Enrollment: 20

Study started: October 2006; Expected completion: March 2009

Several studies have shown an influence of artificial light exposure on menstrual cycles in women. There is an evidence that morning bright light stimulates human female reproductive hormones and increases ovulation. The aim of the first part of the study is to study a relationship between the length of menstrual cycle and the natural light. Menstrual diaries from 200 women without clinically evident endocrine abnormalities will be analyzed. They will be diagnosed if they have (sub-)SAD according to SPAQ and they kept menstrual cycle diaries on a regular basis of at least the 13 last months. The length of menstrual cycles will be correlated with the change of daily hours of sunshine. At the second part of the study (20 women with SAD and 20 women without seasonality (control group)) we will investigate the follicle growth and ovulation occurrence in summer and in winter. The third part will include test of influence of blue-enriched artificial light on follicle growth and ovulation and winter depression. The samples will include at least 15-20 women with (sub-)SAD. Light exposure will be started on Day 5-7 of menstrual cycle and continued for 14 days. The effect of blue-enriched light will be compared with yellow light (placebo-controlled, crossover study). Ultrasound examination will be performed for documentation of ovulation and follicles growth.

Verified by Russian Academy of Medical Sciences April 2007

Sponsored by: Russian Academy of Medical Sciences
Information provided by: Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00467805

Click here for more information at ClinicalTrials.gov

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