Polycystic ovarian syndrome. Polycystic ovarian syndrome
Conditions
Interventions
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 a
Sponsors
Lotus Royan Charitable Fundation
Sagepad Darou Company
Eligibility
Sex/Gender
Female
Age
18 Years to 38 Years
Inclusion 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
Exclusion criteria: 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 ß-blocker before or during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;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 | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZeynab Siahnouri
Royan Institute
Outcome results
None listed