Polycystic Ovary Syndrome Clinical Trial
Official title:
The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial
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.
n/a
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