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IRCT20080831001141N44 IRCT 2023-10-30 Lotus Royan Charitable Fundation Investigating the effect of using cinnamon supplements on IVF cycle results in infertile women with polycystic ovary syndrome 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 2023-11-21 anticipated 80 Complete https://irct.ir/trial/73049 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization allocation will be prepared by the methodologist using the Rand function of Excel software. In this method, the blocks in a size of 6 are used and each person will be given an exclusive code in order to hide the allocation. The details of random allocation in terms of drug and placebo grouping are solely at the disposal of the project's pharmacist colleague, who have no role in the process of sampling and follow-up of patients, Blinding description: The medicine packages, as well as the appearance and smell of cinnamon and placebo tablets, are completely similar to each other. The methodologist prepared the drugs based on the block randomization method and prepared the coded list and put an English three-letter code label on the medicine cans. When an eligible patient is referred to a clinical physician, the principal investigator provides him with an envelope containing a drug code based on a randomized list, and the drug package with the same code is delivered to the patient. In this way, the patient and the clinical doctor following the patient will not know the type of drug (cinnamon or placebo). 3 Polycystic ovarian syndrome. Intervention 1: Intervention group: patients will take 1500 mg daily (3 tablets of cinnamon 500 mg, Sagepad Darou Pharmaceutical Company, Iran) that is, 4 weeks before the start of the new IVF cycle and 2 weeks during the ovarian stimulation process. Intervention 2: Control group: patients take 3 placebo pills daily (containing white wheat flour, which is similar to cinnamon pills in terms of size, shape, color and smell, Sagepad Darou Pharmaceutical Company, Iran) 4 weeks before starting the ovarian stimulation/in vitro fertilization (COS/IVF) cycle and 2 weeks during the ovarian stimulation procedure, the ovary will be stimulated. Yes - There is a plan to make this available What will be shared: The individual data of the participants in the study as well as the data related to the main outcomes of the study without mentioning the names of the patients will be compared and reported between the two groups. When: The access period starts 6 months after the results are published To whom: The study data will be available only to researchers working in academic and scientific institutions. Conditions: Researchers who intend to write a review and meta-analysis study can access the project data and documentation through correspondence with the project facilitator, whose details are provided on the site Where to obtain: To access the documents and raw data, it is necessary to study the administrative correspondence with the research deputy of Royan Institute and correspondence with the respondent whose details have been announced on the site. How to obtain: 6 months after the publication of the article in scientific journals, they can send their request through official correspondence or email with the research deputy of the Royan Institute. Access to the data may take up to one month after the application is submitted. Comments:
public Zeynab Siahnouri
No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
Tehran Iran (Islamic Republic of) 1165659711 +98 21 2356 2640 zeynab.nouri@yahoo.com Royan Institute scientific maryam Hafezi
No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
Tehran Iran (Islamic Republic of) 1165659711 +98 21 2356 2642 maryamhafezi90@gmail.com Royan Institute Iran (Islamic Republic of) 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 18 years 38 years Female Body mass index above 35 kg/m2 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 E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: patients will take 1500 mg daily (3 tablets of cinnamon 500 mg, Sagepad Darou Pharmaceutical Company, Iran) that is, 4 weeks before the start of the new IVF cycle and 2 weeks during the ovarian stimulation process. Control group: patients take 3 placebo pills daily (containing white wheat flour, which is similar to cinnamon pills in terms of size, shape, color and smell, Sagepad Darou Pharmaceutical Company, Iran) 4 weeks before starting the ovarian stimulation/in vitro fertilization (COS/IVF) cycle and 2 weeks during the ovarian stimulation procedure, the ovary will be stimulated. Total number of retrieved oocytes. Timepoint: Day of oocyte pick-up, 32-34 hours after hCG administration (approximately day 10 of ovarian stimulation). Method of measurement: At the point of ovum pick-up, the total number of retrieved oocytes is counted by the embryologist. Therefore, it will be possible to measure the results one hour after oocytes retrieval. Total number of mature (MII) oocytes. Timepoint: Day of oocyte pick-up, 32-34 hours after hCG administration (approximately day 10 of ovarian stimulation). Method of measurement: At the point of ovum pick-up, the total number of retrieved oocytes is counted by the embryologist. Therefore, it will be possible to measure the results one hour after oocytes retrieval. Oocyte recovery ratio. Timepoint: Day of oocyte pick-up, 32-34 hours after hCG administration (approximately day 10 of ovarian stimulation). Method of measurement: This ratio is obtained by dividing the total number of retrieved oocytes by the total number of aspirated follicles from both ovaries. Oocyte maturity rate. Timepoint: Day of oocyte pick-up, 32-34 hours after hCG administration (approximately day 10 of ovarian stimulation). Method of measurement: This ratio is calculated by dividing the number of mature oocytes (MII) obtained by the total number of retrieved oocytes from both ovaries. Fertilization rate. Timepoint: 17-18 h after intracytoplasmic sperm injection and/or in-vitro insemination by checking the number of polar bodies and pronuclei. Method of measurement: The fertilization rate is defined as the ratio between the number of diploid zygotes and the number of mature oocytes. Quality of obtained embryos. Timepoint: 3 days after intracytoplasmic sperm injection or in vitro fertilization (IVF/ICSI) procedure. Method of measurement: Embryo grade is assessed under an inverted microscope 3 days after the intracytoplasmic sperm injection procedure. The quality of embryos is graded from 1 to 3 under inverted microscope 3 days after the intracytoplasmic sperm injection procedure. Embryos with even-sized blastomeres and/or ≤10% fragments is classified as Grade 1 (Excellent or good quality). Grade 2 embryos (moderate or fair quality) have blastomeres with slightly-moderate size differences and/or 10- 20% fragments. Grade 3 embryos (poor quality) have markedly different-sized blastomeres and/or >20% fragments. PI3K gene expression relative to the housekeeping gene. Timepoint: 6 weeks after taking cinnamon supplements (oocyte retrieval day). Method of measurement: After collecting follicular fluid on the day of oocyte retrieval, granulosa cells are extracted from the follicular fluid using a density gradient method. RNA is extracted from the cells using a column kit and converted to complementary DNA (cDNA). Then, gene expression is assessed relative to a control gene using real-time PCR. CYP19A1 gene expression relative to the housekeeping gene. Timepoint: 6 weeks after taking cinnamon supplements (oocyte retrieval day). Method of measurement: After collecting follicular fluid on the day of oocyte retrieval, granulosa cells are extracted from the follicular fluid using a density gradient method. RNA is extracted from the cells using a column kit and converted to complementary DNA (cDNA). Then, gene expression is assessed relative to a control gene using real-time PCR. Calpain10 ‎gene expression relative to the housekeeping gene. Timepoint: 6 weeks after taking cinnamon supplements (oocyte retrieval day). Method of measurement: After collecting follicular fluid on the day of oocyte retrieval, granulosa cells are extracted from the follicular fluid using a density gradient method. RNA is extracted from the cells using a column kit and converted to complementary DNA (cDNA). Then, gene expression is assessed relative to a control gene using real-time PCR. Sagepad Darou Company Lotus Royan Charitable Fundation Pharmaceutical grant Approved 2023-08-08 Ethics Committee of Royan Research Institute No. 12, Hafez Sharghi St., North Bani Hashem St., Shahid Soleimani Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)