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IRCT20241127063875N1 IRCT 2025-01-02 Tehran University of Medical Sciences Investigating The Effect Of Ferula assa-foetida On The Quantity And Quality Of Eggs In Infertile Women With polycystic ovaries Investigating The Effect Of Ferula assa-foetida On The Quantity And Quality Of Eggs In Infertile Women With polycystic ovaries 2025-02-03 anticipated 72 Complete https://irct.ir/trial/80454 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: This study will be a double-blind randomized clinical trial with two intervention and control groups. Sampling will be done after completing the informed consent form using the available method and the samples will be selected based on purpose and will be randomly assigned to two groups of intervention (A) and control (B) using quadruple permutation blocks and through lottery, then the intervention will be started with medication for 16 weeks, Blinding description: Coding of drug and placebo packages will be done in the School of Pharmacy of Shahed University of Medical Sciences and by the research consultant, and until the end of data analysis, the researcher and the patient (samples) will be unaware of the method of drug allocation, therefore, this study will be double-blind. 3 Egg quantity and quality in women with polycystic ovary syndrome. Intervention 1: Intervention group: The intervention will begin with medication for 16 weeks. The intervention will include the daily intake of two Ovulam capsules, each capsule containing 500 mg of oleogum resin from the plant Ferula assa-foetida. Intervention 2: Control group: The control group will also be prescribed two capsules daily, each capsule being the same size and weight as the Ovalamam capsule and containing bread powder, which will be encapsulated at the Traditional Medicine Clinical Trial Research Center at Shahed University. Yes - There is a plan to make this available What will be shared: Because this research is in the form of a thesis, all of the above-mentioned items in this research will be shared in the meetings of the Research Council of the Faculty's Reproductive Health Department and the final defense meeting for the council members. When: When defending the proposal and final defense of the thesis To whom: Research team members, final report reviewers, and stakeholders (pharmacist and gynecologist) Conditions: In addition to the aforementioned data, possible side effects of the drug can also be provided for the purpose of drug manufacturing. Where to obtain: Supervisor Dr. Mehrnaz Garanmayeh Email: geranmay@tums.ac.ir How to obtain: After the request, if the supervisor and the research team deem it appropriate, the information will be sent according to the contract between them. Comments:
public Sajedeh bahjati
Towhid Square, Dr. Mirkhani Street (East Nusrat)
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 Sajedeh.bahjati@yahoo.com Tehran University of Medical Sciences scientific Sajedeh Bahjati
Towhid Square, Dr. Mirkhani Street (East Nusrat)
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 Sajedeh.bahjati@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 40 years2. History of primary or secondary infertility3. Diagnosis of polycystic ovary syndrome based on the opinion of a specialist doctor4. No known mental illness or any illness that affects the fertility process.5. Normal fallopian tubes.6. The absence of infertility in the spouse, according to the doctor's approval. History of primary or secondary infertility Diagnosis of polycystic ovary syndrome based on the opinion of a specialist doctor No known mental illness or any illness that affects the fertility process Normal fallopian tubes The absence of infertility in the spouse, according to the doctor's approval 18 years 40 years Female The presence of a known mental illness or any illness that may affect the reproductive process. Infertility due to abnormal fallopian tubes Infertility in the spouse The presence of any infertility that has a cause other than polycystic ovary syndrome. Egg quantity، Egg quality، Polycystic ovary syndrome Treatment - Drugs Placebo Intervention group: The intervention will begin with medication for 16 weeks. The intervention will include the daily intake of two Ovulam capsules, each capsule containing 500 mg of oleogum resin from the plant Ferula assa-foetida. Control group: The control group will also be prescribed two capsules daily, each capsule being the same size and weight as the Ovalamam capsule and containing bread powder, which will be encapsulated at the Traditional Medicine Clinical Trial Research Center at Shahed University. Egg quantity, which refers to the number of follicles. Timepoint: 16 weeks. Method of measurement: Ultrasound. Tehran University of Medical Sciences Approved 2025-03-05 Ethics Committee of the School of Nursing and Midwifery, Tehran University of Medical Sciences Towhid Square, Dr. Mirkhani Street (East Nusrat) Tehran Tehran Iran (Islamic Republic of)