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IRCT20200908048665N1 IRCT 2023-06-01 Sanandaj University of Medical Sciences Effects of extract of Foeniculum vulgare on patients with polycystic ovary syndrome (PCOS) Effects of extract of Foeniculum vulgare on serum levels of estrogen, progesterone, LH and FSH hormones and miR-499, BMP15 and GDF9 genes expression in granulosa cells of patients with polycystic ovary syndrome (PCOS) 2020-10-22 anticipated 45 Complete https://irct.ir/trial/67587 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, the level of hormones LH, FSH, estrogen, progesterone and the expression level of 499-miR and BMP15 and GDF9 genes in granulosa cells of women with polycystic ovary syndrome as well as two healthy groups and patients without intervention were investigated. The desired measurements were performed before and after the intervention group, but only baseline values were measured in the other two groups. All measurements were among the routine measures for patients presenting with infertility complaints, Randomization description: Individual block randomization was considered by considering fifteen blocks and within each block three groups (A, B, and C) whose order was set randomly. So, finally, the list of 45 people who were assigned to each group was placed in 45 sealed envelopes, with numbers 1 to 45 written on the envelopes, and the study group was recorded inside the envelopes. The arrangement of the groups was done based on the block allocation by the website https://www.sealedenvelope.com, Blinding description: In this study, only the person investigating the results (hormones and expression of desired genes) in the laboratory did not know about the grouping of the patients, but the patients and the researchers were aware of the grouping. 2-3 polycystic ovary syndrome (PCOS). Intervention 1: Intervention group: women with polycystic ovary syndrome (PCOS) treated with fennel extract in the amount of 100 mg twice a day in the form of capsules made by the research group. Intervention 2: Control group: This group was given a placebo in the form of capsules similar to the intervention group, which contained starch, twice a day for 45 days. Yes - There is a plan to make this available What will be shared: Row data will be available. When: After publication To whom: Researchers Conditions: For systematic review and meta-analysis. Where to obtain: Research deputy at Kurdistan University of Medical Sciences How to obtain: Send a request to the research deputy at the University Comments:
public Rojin Ramezani
Pasdaran st., Medical Sciences, Razi Alley 6
Sanandaj Iran (Islamic Republic of) 6616945457 +98 87 3361 1017 Rojin.Ramezani@gmail.com Sanandaj University of Medical Sciences scientific Rojin Ramezani
Pasdaran St., Medical Sciences, Razi Alley 6
Sanandaj Iran (Islamic Republic of) 6616945457 +98 87 3361 7101 Rojin.Ramezani@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) According to the Adams criteria based on ovarian ultrasound manifestations is to have at least 10 cysts with a diameter of 2-8 mm around the central stroma, densely and in the form of a necklace. Having Rotterdam diagnosis criteria (menstrual cycle disorder, clinical symptoms, and diagnosis of polycystic ovary in ultrasound diagnosed by a radiology specialist and infertility fellowship). BMI between 18-22 Age between 20-35 years 20 years 35 years Female Patients with Cushing's syndrome and weight-induced amenorrhea Pituitary disorders Congenital Adrenal Hyperplasia (CAH) Prolactinoma Thyroid disorders Androgen-secreting tumors Hypertension Chronic kidney disease Alcoholics and smokers Previous miscarriage Infertility in their husbands E28.2 Polycystic ovarian syndrome Treatment - Other Placebo Intervention group: women with polycystic ovary syndrome (PCOS) treated with fennel extract in the amount of 100 mg twice a day in the form of capsules made by the research group. Control group: This group was given a placebo in the form of capsules similar to the intervention group, which contained starch, twice a day for 45 days. Serum level of estrogen hormone. Timepoint: Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant). Method of measurement: ELISA test. Serum levels of progesterone. Timepoint: Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant). Method of measurement: ELISA test. FSH serum level. Timepoint: Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant). Method of measurement: ELISA test. LH serum level. Timepoint: Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant). Method of measurement: ELISA test. The expression level of 499-miR. Timepoint: Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant). Method of measurement: Real time PCR. BMP15 gene expression. Timepoint: Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant). Method of measurement: Real time PCR. GDF9 gene expression. Timepoint: Before starting the study and before IVF in three groups and after the intervention in the experimental group (After taking 45 days of ethanol extract of fennel plant). Method of measurement: Real time PCR. Sanandaj University of Medical Sciences Approved 2021-02-17 Ethics Committee of Kurdistan University of Medical Sciences Sanandaj - Pasdaran Ave Sanandaj Kurdistan Iran (Islamic Republic of)