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IRCT20111219008459N15 IRCT 2023-02-05 Tabriz University of Medical Sciences The effect of fennel extract on antimullerian hormone and ultrasound criteria in infertile women with Occult premature ovarian failure The effect of fennel extract on antimullerian hormone and ultrasound criteria in infertile women with Occult premature ovarian failure: a randomized controlled clinical trial. 2023-04-04 anticipated 60 Complete https://irct.ir/trial/67583 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized controlled clinical trial.The participants will be randomly assigned to two groups of 30 with an allocation ratio of 1:1 using the block method of four and six. So that all 6 possible ways of placing the participants in a block of four (2 people in the intervention group and 2 people in the control group) and 19 possible positions in a block of 6 (3 people in the intervention group and 3 people in the control group) with the letters I and C that represent the intervention and control groups, respectively, is written and the random series of number of these arrangements (from 1 to 25) was obtained by using www.randomizing.org. The bottles of medicine or placebo will be numbered from 1 to 60 based on the random order obtained. In order to hide the allocation, it will be done by a person not involved in sampling.The received intervention, i.e. drug or placebo, is placed in numbered opaque glasses, and in this way, participants will be placed in groups, Blinding description: Participants, researcher and data analyst will be unaware of the type of intervention received. The received intervention, i.e. drug or placebo, will be placed in similar opaque glasses (participant blinding). Random allocation and numbering of medicine and placebo bottles will be done by a person not involved in sampling (researcher blinding) and the data analyzer will be unaware of the group allocation (analyzer blinding). 3 Occult premature ovarian insufficiency. Intervention 1: Intervention group: 30 mg fennel capsules manufactured by Barnage Essential Oil Company will be used. One capsule will be consumed daily for 2 months. Intervention 2: Control group: Placebo capsules that are similar in appearance (shape, size, color, etc.) to fennel capsules produced by Barch Essential Oil Company and will be consumed daily by Badmet participants for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Maryam Banaei
Faculty of NURSING and Midwifery, South Shariaty Street
Tabriz Iran (Islamic Republic of) 5168743953 +98 41 3479 6770 future.maryam@yahoo.com Tabriz University of Medical Sciences scientific Maryam Banaei
Faculty of NURSING and Midwifery, South Shariaty Street
Tabriz Iran (Islamic Republic of) 5168743953 +98 41 3479 6770 future.maryam@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 1) Evidence suggesting occult premature ovarian failure: antimullerian hormone > 1, or reduction of ovarian follicular reserve by transvaginal ultrasound (reduction of antral follicles less than 6 in each ovary) 2) Presence of menstrual cycles 3) Age 20-40 years 4) Having Both ovaries 5) No other causes of female infertility including fallopian tube disorders, endocrine system disorders and uterine disorders, endometriosis, hyperprolactinemia and sexual disorders based on the patient's medical record. 6) Not using complementary herbal medicines in the last three months 20 years 40 years Female 1) Alcohol consumption and smoking 2) Obesity, BMI >30 3) Willingness to use donated eggs 4) Having a history of cancer, radiotherapy and chemotherapy 5) People with ovarian cysts and uterine myoma 6) People being treated with the antibiotic ciprofloxacin (46) 7) Presence of menopause symptoms (hot flashes, night sweats) Treatment - Drugs Placebo Intervention group: 30 mg fennel capsules manufactured by Barnage Essential Oil Company will be used. One capsule will be consumed daily for 2 months. Control group: Placebo capsules that are similar in appearance (shape, size, color, etc.) to fennel capsules produced by Barch Essential Oil Company and will be consumed daily by Badmet participants for 3 months Comparison of the number of ovarian antral follicles in the group receiving fennel capsules and the control group. Timepoint: At the beginning of the study (before the start of the intervention) 2 months after the start of the intervention. Method of measurement: Real time transvaginal ultrasound with Madison v20 brand, which is made in South Korea. Comparison of AMH levels in the group receiving fennel capsules and the control group. Timepoint: At the beginning of the study (before the start of the intervention) 2 months after the start of the intervention. Method of measurement: AMH laboratory kit. Tabriz University of Medical Sciences Approved 2023-01-28 Ethics Committee of Tabriz University of Medical Sciences South Shariati Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)