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IRCT20171209037794N5 IRCT 2023-10-01 Babol University of Medical Sciences The effect of oral melatonin supplementation on the number and quality of oocytes and embryos in infertile women with endometriosis The effect of oral melatonin supplementation on the number and quality of oocytes and embryos in infertile women with endometriosis and undergoing intracytoplasmic sperm insemination 2023-10-02 anticipated 100 Complete https://irct.ir/trial/72392 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomized block allocation method will be applied. The number of considered blocks is 4. Randomization will be done using a dedicated online randomization software (http://www.randomization.com). The allocation sequence is password protected and accessible only to an independent investigator not involved in the study, Blinding description: The drug and placebo, which have the same size, color, taste, and smell, are provided to both groups in completely similar containers based on random allocation by the design partner. Therefore, none of the patients are aware of the assigned treatment and will not be informed until the end of the study. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used. 3 Endometriosis. Intervention 1: Intervention group: patients will receive 5 mg melatonin tablet (Jalinous Pharmacetical Company), one hour before sleep, once a day for 2 months. Intervention 2: Control group: patients will receive placebo (Jalinous Pharmacetical Company) once a day for 2 months. Yes - There is a plan to make this available What will be shared: - When: - To whom: - Conditions: - Where to obtain: - How to obtain: - Comments:
public Parvaneh Mirabi
Babol University of Medical Sciences, Ganj Afrooz Stereet, Babol, Mazandaran
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 0558 parvaneh_mirabi@yahoo.com Babol University of Medical Sciences scientific Parvaneh Mirabi
Babol University of Medical Sciences, Ganj Afrooz Stereet, Babol, Mazandaran
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 0558 parvaneh_mirabi@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Infertile women 20 to 40 years old under ART treatment along with laparoscopy or ultrasound report indicating the presence of endometriosis 20 years 40 years Female Premature ovarian failure. severe male factor according to the criteria (WHO), sperm count less than 15 million per milliliter and motility less than 50% and normal morphology less than 4%. Occurrence of complications and drug sensitivity such as (fatigue, headache, blurred vision, nausea, diarrhea). Diagnosis of adenomyosis and chronic diseases including thyroid, adrenal diabetes, current malignancy or history of malignancy, uterine myoma and PID . Patients whose infertility is due to obstruction problems, genetic problems or hormonal problems. N80 Endometriosis Treatment - Drugs Treatment - Drugs Intervention group: patients will receive 5 mg melatonin tablet (Jalinous Pharmacetical Company), one hour before sleep, once a day for 2 months. Control group: patients will receive placebo (Jalinous Pharmacetical Company) once a day for 2 months. Number and quality of embryos. Timepoint: 24 hours after ICSI. Method of measurement: Microscopic assay. The number and quality of oocytes. Timepoint: oocyte pick up day. Method of measurement: Microscopic Assay. Fertilization rate. Timepoint: 24 hours after ICSI. Method of measurement: Microscopic Assay. Babol University of Medical Sciences Approved 2023-09-17 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences- Ganj Afrooz street. Babol Mazandaran Iran (Islamic Republic of)