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IRCT20211204053267N1 IRCT 2021-12-30 Tarbiat Modars University The effect of administering L-Carnitine to Clomiphene citrate stimulated cycles on conception rate and ovulation in infertile women with polycystic ovary syndrome The effect of administering L-Carnitine to Clomiphene citrate stimulated cycles on ovulation and conception rate in infertile women with polycystic ovary syndrome: a randomized controlled clinical trial in Kabul. 2022-01-21 anticipated 32 Complete https://irct.ir/trial/60405 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first stage, the research units will be divided into two groups of intervention and control based on the inclusion and exclusion criteria of screening and then block randomization using quadruple random blocks. This method strikes a balance in the allocated samples. In this way, we first design blocks of 4 types of available probabilities, so that in each block there are two people from the intervention group and two people from the control group. The number of probabilities in this case will be equal to 6.AABB(1)-BBAA(2)-ABBA(3)- BAAB(4)- BABA(5)- ABAB(6). Then the list of available modes is prepared and numbered by the tutor, and the statics specialist sort the blocks based on random numbers from 1 to 6. Matte envelopes in the package will be used in numbered order to hide the allocation. The researcher randomly picks up the envelopes and then enters the research units into the sampling system in order, Blinding description: This study will be a phase 1 three-blind clinical trial with placebo control group. The method of blinding is that the researcher and the research units and statistical analysts will also be unaware of the type of drug used, and the placebo drug will be prepared by the pharmacist in the same form and with a special code and will be provided to the research units. Participants and researchers will be unaware of the drug codes and only the pharmacist will determine the drug code and after collecting and completing the study, these codes will be decoded. 3 Infertility. Intervention 1: Intervention group: 16 people will be randomly selected, considering the sample size. L-Carnitine capsule 1000 mg from the American company called Pride Puritan's (2 capsules of 1 gram) daily with first-line infertility treatment drug ( Clomiphene citrate tablets with a dose of 100 mg from day 3 to 9 of the menstrual cycle) will be used orally in the intervention group. Intervention 2: Control group: In the control group, placebo capsule similar to L-carnitine, which will contain powdered milk and will be produced by the same company (Puritan's Pride) (2 capsules) daily with first-line infertility treatment drug (clomiphene tablets100 mg) from day 3 to 9 of the menstrual cycle will be used orally. No - There is not a plan to make this available Justification or reason for not sharing IPD is To keep the security of data
public Shadab Shahali
Jalal al Ahmad
Tehran Iran (Islamic Republic of) 1411716911 +98 21 8288 3811 shadab.shahali@modares.ac.ir Tarbiat Modares University scientific Shadab Shahali
Jalal al Ahmad
Tehran Iran (Islamic Republic of) 1411716911 +98 21 8288 3811 shadab.shahali@modares.ac.ir Tarbiat Modares University Afghanistan Afghanistan 20-35 years old women Primary infertility due to polycystic ovary syndrome diagnosed according to Rotterdam criteria by a gynaecologist Having regular vaginal intercourse in the last year 20 years 35 years Female Infertility with other causes (such as male causes, tubular causes, etc.) Allergy to L-Carnitine Pregnancy or lactation Antimullerian hormone less than the normal range for age Having chronic diseases The body mass index (BMI) over30 Using other antioxidants or supplements Using insulin releasing drugs, lipid-lowering agents, antiepileptic drugs, drugs with effects on endocrine system and carbohydrate metabolism from 3 months before the start of the study N97.0 Female infertility associated with anovulation Treatment - Drugs Placebo Intervention group: 16 people will be randomly selected, considering the sample size. L-Carnitine capsule 1000 mg from the American company called Pride Puritan's (2 capsules of 1 gram) daily with first-line infertility treatment drug ( Clomiphene citrate tablets with a dose of 100 mg from day 3 to 9 of the menstrual cycle) will be used orally in the intervention group Control group: In the control group, placebo capsule similar to L-carnitine, which will contain powdered milk and will be produced by the same company (Puritan's Pride) (2 capsules) daily with first-line infertility treatment drug (clomiphene tablets100 mg) from day 3 to 9 of the menstrual cycle will be used orally The primary outcome of the study will be chemical pregnancy rate which means that β -HCG is more than 5 ml / ml, which is detected on the first day of the last menstrual cycle (LMP) at week 4-5 without the fetal heart and Or the pregnancy sac will be visible on ultrasound at 6-7 weeks. Timepoint: 3 times with intervals of 1 month. Method of measurement: Using a laboratory assay, β -HCG more than mIU/mL based on the first day of the last menstrual cycle (LMP) at week 4-5. The LH hormone will be checked on the eighteenth to the twenty-second day of cycle after drug administration, which is normal in the luteal phase (0.61 to 16.3 IU/L). If the level of this hormone is reported outside the range compared to the first test of this ovulation stimulation hormone from the laboratory, it will be considered as the lack of effect of this drug on the ovulation cycle. Timepoint: The LH levels will be checked on the eighteenth to the twenty-second day after the drug is administered. Method of measurement: The normal level of LH in the luteal phase is (0.61 to 16.3 IU/L). Number of antral follicles in infertile women with polycystic ovary syndrome, on the twelfth day of the menstrual cycle to the 22nd day of the menstrual cycle after the intervention. Timepoint: For 3 months, after the twelfth day of the menstrual cycle, every two days, serially until the 22nd day of the menstrual cycle to evaluate the effect of the drug on the ovary and polycystic ovary syndrome will be performed using transvaginal ultrasound. Method of measurement: Using transvaginal ultrasound. Clinical pregnancy in infertile women with polycystic ovary syndrome, after intervention. Timepoint: Monthly, 6-7 weeks from the first day of the last menstrual period for 3 months. Method of measurement: Finding the pregnancy sac and fetal heart using ultrasound at 6-7 weeks from the first day of the last menstrual period. Antimullerian hormone levels in infertile women with polycystic ovary syndrome, on the third day of the cycle. Timepoint: Monthly in the third day of menstruation will evaluate the antimullerian hormone (AMH) levels after the drug is administered. Method of measurement: This hormone is measured in infertile women with polycystic ovary syndrome on the third day of menstruation until the next cycle of bleeding, which is considered according to the patient's age according to the laboratory cut-off kit. Tarbiat Modars University Approved 2021-12-25 Tarbiat Modares University Biomedical Research Ethics Committee Pol Nasr Jalal Al ahmad Tehran Iran (Islamic Republic of)