Status:
RECRUITING
Cinnamon and COH in PCOS Women Underdoing IVF/ICSI Cycles
Lead Sponsor:
Royan Institute
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-38 years
Phase:
NA
Brief Summary
In patients with polycystic ovary syndrome, insulin resistance increases, and since the extracts from cinnamon reduces insulin resistance by two mechanisms (1- increasing activation of the IRS/PI-3 ki...
Detailed Description
This double-blind randomized clinical trial will be conducted in Royan Institute on patients with polycystic ovary syndrome undergoing in vitro fertilization cycle treatment to evaluate the effect of ...
Eligibility Criteria
Inclusion
- Infertile women with polycystic ovary syndrome (PCOS) diagnosed according to the Rotterdam criteria who meet at least 2 of the following three criteria including: (1) oligomenorrhea or anovulation, (2) hyperandrogenism (clinical or biochemical ng/ dL 80 ≤ serum T level), (3) the presence of polycystic ovaries in ultrasound).
- The age range of 18 to 38 year.
- Written consent to participate in the study
Exclusion
- Body mass index above 35 kg/m2
- Chronic and Endocrine disorders including diabetes mellitus, hyperprolactinemia, hypertension, Cushing's syndrome
- Autoimmune disorders
- History of recurrent pregnancy loss
- Genital, ovarian or uterine abnormalities
- Hydrosalpinx diagnosis
- Congenital adrenal hyperplasia, androgen-producing tumors or acromegaly
- Sensitivity to cinnamon
- Daily and frequent consumption of cinnamon to treat infertility
- Severe male factor infertility
- Moderate to severe endometriosis diagnosis Use of other hypoglycemic, insulin-sensitizing drugs (e.g. Metformin) or other antioxidant supplement (e.g. Myo-inositol) and β-blocker before or during the study
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 21 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06199024
Start Date
November 21 2023
End Date
February 21 2026
Last Update
January 10 2024
Active Locations (1)
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1
Royan Institute
Tehran, Iran, 1665659911