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Trial record 56 of 110 for:    inositol

Graceful Lifestyle Changes Study for PCOS and Infertility (GLC)

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ClinicalTrials.gov Identifier: NCT02630485
Recruitment Status : Unknown
Verified December 2015 by University of British Columbia.
Recruitment status was:  Not yet recruiting
First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility Behavioral: Graceful Lifestyle Changes Dietary Supplement: Myo-inositol Drug: Letrozole Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Graceful Lifestyle Changes Intervention Study for Women With PCOS and Infertility
Study Start Date : December 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Graceful Lifestyle Changes & MYO

The 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness.

In addition, this group will take myo-inositol (6 grams in juice or water every morning).

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.
Other Name: GLC

Dietary Supplement: Myo-inositol
Myo-inositol will be consumed in juice or water every morning (6 grams) for 12 weeks.
Other Names:
  • Inositol
  • MYO

Experimental: Graceful Lifestyle Changes

The 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness.

In addition, this group will take a white powder placebo (6 grams in juice or water every morning).

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.
Other Name: GLC

Placebo Comparator: Letrozole & MYO

The women assigned to the fertility medication group will be prescribed letrozole. 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.

In addition, this group will take myo-inositol (6 grams in juice or water every morning).

Dietary Supplement: Myo-inositol
Myo-inositol will be consumed in juice or water every morning (6 grams) for 12 weeks.
Other Names:
  • Inositol
  • MYO

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.

Placebo Comparator: Letrozole

The women assigned to the fertility medication group will be prescribed letrozole. 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.

In addition, this group will take a white powder placebo (6 grams in juice or water every morning).

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.




Primary Outcome Measures :
  1. Ovulation Occurence [ Time Frame: 12 weeks ]
    Ovulation is the primary outcome and expressed as any ovulation (categorical "yes" or "no") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.

  2. Ovulation Frequency [ Time Frame: 12 weeks ]
    Ovulation is the primary outcome can be expressed in according to frequency (nominal "0", "1", "2, or "3") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.


Secondary Outcome Measures :
  1. Conception [ Time Frame: 12 weeks ]
    If ovulation occurs but menses does not follow, a pregnancy test will be administered.

  2. Stress [ Time Frame: 12 weeks ]
    Stress will be assessed by the Depression Anxiety and Stress Scale (DASS) at the beginning and end of the 12 weeks.

  3. Anxiety [ Time Frame: 12 weeks ]
    Anxiety will be assessed by the Depression Anxiety and Stress Scale (DASS) at the beginning and end of the 12 weeks.

  4. Depression [ Time Frame: 12 weeks ]
    Depression will be assessed by the Depression Anxiety and Stress Scale (DASS) at the beginning and end of the 12 weeks.

  5. Quality of Life [ Time Frame: 12 weeks ]
    Quality of life will be assessed by the Fertility Quality of Life Questionnaire (FertiQoL) at the beginning and end of the 12 weeks..



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all women with PCOS trying to conceive who are between 18 and 37 years of age (PCOS will be defined using the Rotterdam criteria)

Exclusion Criteria:

  • women who have already began fertility treatment
  • women who are taking myo-inositol or have taken it in the past three months
  • women being treated for or who have a history of an eating disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630485


Contacts
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Contact: Anthony P Cheung, MBBS MPH MBA 604-558-4886 ACheung@fertilitywithgrace.com
Contact: Dylan A Cutler, BSc 604-727-3447 dacutl08@gmail.com

Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Anthony P Cheung, MBBS MPH MBA Grace Fertility Centre & Reproductive Medicine

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02630485     History of Changes
Other Study ID Numbers: H13-02964
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Keywords provided by University of British Columbia:
Randomized Controlled Trial
Additional relevant MeSH terms:
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Inositol
Polycystic Ovary Syndrome
Infertility
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances