The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial Phase: III Population: 118 women with polycystic ovary syndrome will be recruited from Obstetrics and Gynecology clinics in King Abdul-Aziz University Hospital, Jeddah 2019. Subject Participation Duration: Each participant will be followed for three months. Intervention: 2g of cinnamon capsules daily will be provided. Objectives: Primary Objective: To compare the effectiveness of cinnamon supplement in combination with clomiphene citrate versus clomiphene citrate alone on ovulation in women with PCOS, in King Abdul-Aziz University Hospital in Jeddah 2019. To measure the difference in insulin resistance after three months of cinnamon supplementation in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019. To determine the effect of cinnamon and CC on menstrual cyclicity, approximated by menstrual frequency, during the study period, in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019 To evaluate the quality of life in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019. Secondary Objectives: To measure the pregnancy rate in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019 Description of Study Design: The participants will be randomized in 1:1 fashion. Allocation concealment will be ensured using similar bottles labeled by letters A and B, to receive either the combination of cinnamon supplement and clomiphene citrate or clomiphene citrate with placebo. First visit: Patients will be evaluated during the early follicular phase for progesterone level and HOMA-IR and QUICK-I. Follow up: 3 months. Last Visit: Patients will be re-evaluated to compare the difference.

Official Title
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The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial

Conditions
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Polycystic Ovary Syndrome, Ovulation

Intervention / Treatment
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* Drug: Cinnamon Cap 500 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Married women aged 18-40 seeking to become pregnant, meeting the Rotterdam criteria for polycystic ovary syndrome Exclusion Criteria: Current pregnancy or lactation. Current use of treatment of infertility. Established diagnosis of diabetes mellitus. Use of Insulin-sensitizing treatment within the past three months. Hormonal treatment involving estrogen or progesterone within the past three months. Known hypersensitivity to cinnamon. Use of statin medication. Any other supplements that contain cinnamon within the past month. BMI <18.5 or BMI >35.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinnamon Group<br>Two capsules of cinnamon 500mg twice per day after meals (2g/day). All capsules will be given simultaneously with the clomiphene citrate medication (standard treatment for infertility in women with PCOS). Participants will be asked to keep their normal lifestyle including daily food and physical activity level. | Drug: Cinnamon Cap 500 MG<br>* The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.<br>|
| Placebo Comparator: Placebo Group<br>Placebo capsules will contain 450 mg of starch and 50 mg of cinnamon powder (to improve blindness regarding taste and odor). Color, shape, and size of placebo capsules will be exactly the same as the cinnamon capsules. 2g/day along with clomiphene citrate | Drug: Placebo<br>* 450 mg of starch and 50 mg of cinnamon powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation Confirmation by Progesterone level | Progesterone level > 3ng/mL or pregnancy confirmed | 3 months | 
| Changes in insulin resistance | HOMA-IR | 3 months | 
| Menstrual frequency | No. of menses/ No. of months | 3 months | 
| Quality of life: Infertility quality of life questionnaire | The 36 FertiQoL items are rated according to 5 types of response scales. The response scales are: Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4) Always (0), very often (1), quite often (2), Seldom (3), never (4) An extreme amount (0), very much (1), a moderate amount (2), a little (3), not at all (4) Completely (0), a great deal (1), moderately (2), not much (3), not at all (4) Scores on the response scales are reversed, summed and scaled to range from 0 to 100. Higher scores on the subscales and total scores indicate better quality of life. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | Number of pregnancies including live births, induced abortions, and fetal deaths / Number of women aged 18 - 40 years) × 1,000 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Ovulation, Cinnamon