Clinical trial NCT03778099: The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome
Official title: The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Ovulation
Keywords: PCOS
Ovulation
Cinnamon
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ovulation Confirmation by Progesterone level
timeFrame: 3 months
measure: Changes in insulin resistance
timeFrame: 3 months
measure: Menstrual frequency
timeFrame: 3 months
measure: Quality of life: Infertility quality of life questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Pregnancy Rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
Study officials:
name: Wael H Alzhrani
role: PRINCIPAL_INVESTIGATOR
References: