Clinical trial · Interventional
Graceful Lifestyle Changes Study for PCOS and Infertility
Graceful Lifestyle Changes Intervention Study for Women With PCOS and Infertility
NCT02630485CI-TRIAL-00020202GLCunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Graceful Lifestyle Changes | Behavioral | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
| Myo-inositol | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Graceful Lifestyle Changes & MYO
- description
- 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).
- interventionNames
- Behavioral: Graceful Lifestyle Changes
- Dietary Supplement: Myo-inositol
- type
- EXPERIMENTAL
- label
- Graceful Lifestyle Changes
- description
- 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).
- interventionNames
- Behavioral: Graceful Lifestyle Changes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 37 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDBarr S, Reeves S, Sharp K, Jeanes YM. An isocaloric low glycemic index diet improves insulin sensitivity in women with polycystic ovary syndrome. J Acad Nutr Diet. 2013 Nov;113(11):1523-1531. doi: 10.1016/j.jand.2013.06.347. Epub 2013 Aug 30. PMID 23999280
- BACKGROUNDBarnard L, Ferriday D, Guenther N, Strauss B, Balen AH, Dye L. Quality of life and psychological well being in polycystic ovary syndrome. Hum Reprod. 2007 Aug;22(8):2279-86. doi: 10.1093/humrep/dem108. Epub 2007 May 30. PMID 17537782
- BACKGROUNDCostantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10. PMID 19499845
- BACKGROUNDDunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997 Dec;18(6):774-800. doi: 10.1210/edrv.18.6.0318. PMID 9408743
- BACKGROUNDHutchison SK, Stepto NK, Harrison CL, Moran LJ, Strauss BJ, Teede HJ. Effects of exercise on insulin resistance and body composition in overweight and obese women with and without polycystic ovary syndrome. J Clin Endocrinol Metab. 2011 Jan;96(1):E48-56. doi: 10.1210/jc.2010-0828. Epub 2010 Oct 6. PMID 20926534
- BACKGROUNDLudwig DS, Kabat-Zinn J. Mindfulness in medicine. JAMA. 2008 Sep 17;300(11):1350-2. doi: 10.1001/jama.300.11.1350. No abstract available. PMID 18799450
- BACKGROUNDMatchim Y, Armer JM, Stewart BR. Effects of mindfulness-based stress reduction (MBSR) on health among breast cancer survivors. West J Nurs Res. 2011 Dec;33(8):996-1016. doi: 10.1177/0193945910385363. Epub 2010 Oct 18. PMID 20956583
- Papaleo E, Unfer V, Baillargeon JP, De Santis L, Fusi F, Brigante C, Marelli G, Cino I, Redaelli A, Ferrari A. Myo-inositol in patients with polycystic ovary syndrome: a novel method for ovulation induction. Gynecol Endocrinol. 2007 Dec;23(12):700-3. doi: 10.1080/09513590701672405. Epub 2007 Oct 10.