A randomized controlled trial comparing lifestyle intervention to letrozole for ovulation in women with polycystic ovary syndrome: a study protocol

Dylan A Cutler, Alana K Shaw, Sheila M Pride, Mohamed A Bedaiwy, Anthony P Cheung, Dylan A Cutler, Alana K Shaw, Sheila M Pride, Mohamed A Bedaiwy, Anthony P Cheung

Abstract

Background: Polycystic ovary syndrome (PCOS) affects between 8 and 18% of women and is the leading cause of female anovulatory infertility. Unfortunately, common treatments for women trying to conceive can be ineffective as well as disruptive or harmful to patients' quality of life. Despite evidence that women with PCOS have expressed the need for alternative fertility treatments, lifestyle interventions incorporating a nutritional plan with supplementation, increased physical activity, and techniques for stress management have not been combined as a program and studied in this population. Literature suggests that each of these individual components can positively influence reproductive hormones and metabolic health.

Methods/design: This is a randomized controlled trial which will include 240 women diagnosed with PCOS, according to the Rotterdam criteria, who are trying to conceive. Participants will be randomized to either a comprehensive lifestyle intervention program or prescribed an oral fertility medication, letrozole. These two groups will be further randomized to consume either myo-inositol or a placebo. Participants will be between the ages of 18 and 37 years. Exclusion criteria include women who have already begun fertility treatment, who are currently using myo-inositol or have taken it within the past 3 months, or who are being treated for, or have a history of, an eating disorder. The primary outcome will be the ovulation rate, the secondary outcome will be conception. Other outcomes include miscarriage rates, validated rating measures of overall quality of life (including social, relational, mind/body and emotional sub-categories) and mental health scores (depression, anxiety, and stress).

Discussion: This trial will determine the effectiveness of a structured lifestyle-based comprehensive intervention program for women with PCOS experiencing infertility. In addition, it will determine whether supplementing with myo-inositol provides any further benefit. The objective of this study is to assess a possible non-pharmacological solution to ovulatory dysfunction in these patients and perhaps improve other associated features of PCOS.

Trial registration: ClinicalTrials.gov, ID: NCT02630485 . Registered on 15 December 2015.

Keywords: Infertility; Lifestyle; Ovulation; Polycystic ovary syndrome.

Conflict of interest statement

Ethics approval and consent to participate

This trial has been approved by the University of British Columbia Children’s and Women’s Research Ethics Board (H13-02964) on 22 January 2018.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participants will be randomized into two groups: the “Graceful Lifestyle Changes” (GLC) group and the oral medication group. Both groups will be further randomized to receive either myo-inositol or its placebo
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessments

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