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Graceful Lifestyle Changes Study for PCOS and Infertility

NCT02630485 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-12-15

No results posted yet for this study

Summary

The purpose of this study is to help women with PCOS to improve their symptoms and ovulation rate through a lifestyle intervention program which introduces a specific diet, a physical activity regimen and mindfulness exercises to improve psychological well-being and overall health.

Conditions

Interventions

BEHAVIORAL

Graceful Lifestyle Changes

Participants will be educated in small groups of 8-10. A wellness booklet designed by physicians and researchers at Grace Fertility Centre will be provided.The target diet for our study is 45% carbohydrates and 55 grams of glycemic load. Participants will keep a 3-day food diary at baseline, 4, 8 and 12 weeks. Secondly, participants will be provided a pedometer and a goal to reach 10,000 steps a day. The third aspect of the program will be to decrease overall stress through mindfulness. Educational sessions will be held to teach the relaxation response and meditation techniques such as breathing and grounding exercises. Participants will be required to meditate for at least 20 minutes each day and record this.

DIETARY_SUPPLEMENT

Myo-inositol

Myo-inositol will be consumed in juice or water every morning (6 grams) for 12 weeks.

DRUG

Letrozole

Letrozole will be administered to patients. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Anthony P Cheung, MBBS MPH MBA · Grace Fertility Centre & Reproductive Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-03-31
Completion
2018-08-31

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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 NCT02630485 on ClinicalTrials.gov