Cinnamon supplementation for women with PCOS undergoing IVF
The Effect of Cinnamon Supplementation on Infertility Treatment Outcomes in Infertile Women With Polycystic Ovary Syndrome (PCOS) Candidate of in Vitro-fertilization (IVF): A Pilot Double Blind Randomized Controlled Clinical Trial
This study tests if taking cinnamon can help women with PCOS who are going through IVF improve their insulin resistance and fertility outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Royan Institute Government |
| Locations | 1 site (Tehran) |
| Trial ID | NCT06199024 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of oral cinnamon supplementation on women with polycystic ovary syndrome (PCOS) who are undergoing in vitro fertilization (IVF) cycles. The study aims to evaluate whether cinnamon can improve insulin resistance and related symptoms in these patients, potentially enhancing their fertility outcomes. Participants will be randomly assigned to receive either cinnamon or a placebo during their controlled ovarian stimulation phase. The trial will include women diagnosed with PCOS based on specific criteria, and their progress will be monitored throughout the IVF process.
Who should consider this trial
Good fit: Ideal candidates are infertile women aged 18 to 38 with a diagnosis of PCOS meeting specific criteria.
Not a fit: Patients with a body mass index above 35 kg/m2 or those with certain chronic or endocrine disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve fertility outcomes for women with PCOS undergoing IVF.
How similar studies have performed: While the use of cinnamon for insulin resistance is promising, this specific approach in the context of IVF for PCOS is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Tehran
- Royan Institute — Tehran, Iran, Islamic Republic of (Recruiting)
Study contacts
- Study coordinator: Maryam Hafezi, M.D
- Email: maryamhafezi90@gmail.com
- Phone: +98 21 2356 2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.