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Completed

NCT Number: NCT03778099

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

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:

1. 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. 2. 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. 3. 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 4. 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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Ovulation Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

King Abdulaziz University

Jeddah, 21589, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cinnamon Cap 500 MG

Drug

The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.

Placebo

Drug

450 mg of starch and 50 mg of cinnamon powder

Primary outcomes

  1. Ovulation Confirmation by Progesterone level

    Time frame: 3 months

    Progesterone level > 3ng/mL or pregnancy confirmed

  2. Changes in insulin resistance

    Time frame: 3 months

    HOMA-IR

  3. Menstrual frequency

    Time frame: 3 months

    No. of menses/ No. of months

  4. Quality of life: Infertility quality of life questionnaire

    Time frame: 6 months

    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.

Secondary outcomes

  1. Pregnancy Rate

    Time frame: 3 months

    Number of pregnancies including live births, induced abortions, and fetal deaths / Number of women aged 18 - 40 years) × 1,000

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Acronym: PCOS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2018
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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