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IRCT20080831001141N42 IRCT 2023-07-19 Royan Institute The effect of L-carnitine supplementation on the results of infertility treatment cycle in women with polycystic ovary syndrome The effect of adding L-carnitine during ovarian stimulation with antagonistic protocol in patients with polycystic ovarian syndrome (PCOS) on the outcome of in-vitro fertilization/intracytoplasmic sperm injection (IVF / ICSI) cycle: A double-blind randomized clinical trial 2020-03-01 anticipated 110 Complete https://irct.ir/trial/63411 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The medicine packages, as well as the appearance and smell of L-carnitine and placebo tablets, are completely similar to each other. The methodologist prepared the drugs based on the block randomization method and prepared the coded list and put an English three-letter code label on the medicine cans. When an eligible patient is referred to a clinical physician, the principal investigator provides him with an envelope containing a drug code based on a randomized list, and the drug package with the same code is delivered to the patient. In this way, the patient and the clinical doctor following the patient will not know the type of drug (L-carnitine or placebo), Blinding description: The patients in the control group will receive 3 placebo tablets for 8 weeks. All the placebo tablets were produced by Karen company (Tehran, Iran), which is approved by the Food and Drug Administration of Iran. The appearance of the placebo was indistinguishable in color, shape, size, and smell from L-carnitine tablets. 3 Polycystic ovary syndrome disorder. Intervention 1: In the experimental group: patients receive 3 grams daily (3 tablets of L-carnitine 1000 mg, Karen Pharmaceutical Company, Iran) from the second day of menstruation of the previous cycle until the day of the pregnancy test (for 8 weeks). Intervention 2: In the control group: patients receive 3 placebo tablets daily (containing cellulose similar to L-carnitine tablets in terms of size, shape, color, and smell, Karen Pharmaceutical Company, Iran) from the second day of menstruation of the previous cycle until the day of the pregnancy test (for 8 weeks). Yes - There is a plan to make this available What will be shared: The personal data of the participants in the study as well as the data related to the main outcome will be reported between the two groups without mentioning their names. When: The access period starts 6 months after the results are published To whom: The study data will be available only to researchers working in academic and scientific institutions Conditions: Researchers who intend to write a review and meta-analysis study can access the project data and documentation through correspondence with the project facilitator, whose details are provided on the site. Where to obtain: To access the documents and raw data, it is necessary to study the administrative correspondence with the research deputy of Royan Institute and correspondence with the respondent whose details have been announced on the site. How to obtain: 6 months after the publication of the article in scientific journals, they can send their request through official correspondence or email with the research deputy of the Royan Institute. Access to the data may take up to one month after the application is submitted. Comments:
public Arezoo Arabipoor
No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
Tehran Iran (Islamic Republic of) 1165659711 +98 21 2356 2640 arezoo.arabipoor@gmail.com Royan Institute scientific Maryam Hafezi
No. 12, Shahid Soleimani Highway, Bani Hashem St., East Hafez St., Royan Institute
Tehran Iran (Islamic Republic of) 1165659711 +98 21 2356 2642 maryamhafezi90@yahoo.com Royan Institute Iran (Islamic Republic of) Patients between 20 to 37 years old, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received two to three failures of intrauterine insemination (IUI) cycle therapy were included. The diagnosis was based on a complete history taking, physical examination, and a complete file documented infertility work-up within the previous 6 months, either conducted within the setting of the hospital or at a licensed infertility management clinic. no limit 37 years Female Patients diagnosed with hyperprolactinemia, diabetes mellitus, epilepsy, and/or any chronic endocrine and cardiovascular diseases Patients are treated with a special diet, medication supplement (ovaboost), and metformin before or during ovarian stimulation History of pelvic surgery on ovaries and uterus Presence of submucosal and intramural fibroids larger than 5 cm or the presence of uterine polyps and congenital uterine malformations The cause of severe male infertility (sperm extraction through surgery) E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo In the experimental group: patients receive 3 grams daily (3 tablets of L-carnitine 1000 mg, Karen Pharmaceutical Company, Iran) from the second day of menstruation of the previous cycle until the day of the pregnancy test (for 8 weeks). In the control group: patients receive 3 placebo tablets daily (containing cellulose similar to L-carnitine tablets in terms of size, shape, color, and smell, Karen Pharmaceutical Company, Iran) from the second day of menstruation of the previous cycle until the day of the pregnancy test (for 8 weeks). Total number of retrieved oocytes. Timepoint: Day of oocyte pick-up, 32-34 hours after hCG administration (approximately Stimulation Day 10). Method of measurement: At the point of ovum pick-up, we can count the total number of retrieved oocytes. Therefore, in one hour after ovum pick-up, outcome measurement will be possible. Total number of mature (MII) oocytes. Timepoint: Day of oocyte pick-up, 32-34 hours after hCG administration (approximately Stimulation Day 10). Method of measurement: At the point of ovum pick-up, we can count the total number of mature (MII) oocytes. Therefore, in one hour after ovum pick-up, outcome measurement will be possible. Fertilization rate. Timepoint: 17-18 h after intracytoplasmic sperm injection and/or in-vitro insemination by checking the number of polar bodies and pronuclei. Method of measurement: The fertilization rate was defined as the ratio between the number of diploid zygotes and the number of mature oocytes. Quality of obtained embryos. Timepoint: 3 days after IVF/ICSI procedure. Method of measurement: Embryo grade was assessed under an inverted microscope 3 days after the intracytoplasmic sperm injection procedure. The quality of embryos was graded from 1 to 3 under inverted microscope 3 days after the intracytoplasmic sperm injection procedure. Embryos with even-sized blastomeres and/or ≤10% fragments were classified as Grade 1 (Excellent or good quality). Grade 2 embryos (moderate or fair quality) had blastomeres with slightly-moderate size differences and/or 10- 20% fragments. Grade 3 embryos (poor quality) had markedly different-sized blastomeres and/or >20% fragments. Clinical pregnancy rate. Timepoint: 7 weeks after embryo transfer. Method of measurement: It was defined as the presence of a gestational sac with a heartbeat under vaginal ultrasonography. NCT04672720 Clinical trials.gov Royan Institute Approved 2018-10-10 Ethics Committee of Royan Research Institute No. 12, Hafez Sharghi St., North Bani Hashem St., Shahid Soleimani Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)