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IRCT20200925048836N3 IRCT 2022-10-21 Shiraz University of Medical Sciences The effect of assisted reproductive drugs in endometriosis patients comparing single dose and double dose of Gonadotropin-releasing hormone (GNRH ) agonist in endometriosis triggering undergoing assisted reproductive technology (ART) cyle 2022-11-06 anticipated 80 Complete https://irct.ir/trial/65994 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The treatment allocation list is already designed on Block Balanced Randomization Method by software ( https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html) (D), 2 (ِD), 3 (D), 4 (S), 5 (S),……. Any eligible patient will be given a 1 to 80 code after obtaining informed consent in order to visit the clinic and based on above block, they receive S or D drug. Patients information will be collected through an interview with the patients. Randomization will be performed by an experienced nurse using a random number table. The patient, embryologist, gynecologist and statistician will be unaware of the groupings, Blinding description: Patients will receive S or D medication based on randomized block in double blind method and a code will be allocated to each patient (1 to 80) that will be encoded at the end of the study. The patients and the designer and drug distributer are not aware of the drug pack. This study is the second phase of trial . 2-3 Infertility. Intervention 1: In intervention group 1 (D), on day 2 or 3 of the menstrual cycle, controlled ovarian stimulation with recombinant FSH (Gonal-f, merck senoro) at a dose of 175-112.5 IU / DAY will be performed for 4 days. FSH dose based on ovarian response and serum estradiol level It will be adjusted when the target follicle is more than 14 mm and the serum concentration of estradiol is more than 300 pg / ml. The antagonist-Ganirelix drug (Orgalutran, Organon) will be used at a subcutaneous dose of 0.25 mg / day. Follicle development will be monitored by transvaginal ultrasound with a 4-8 MHz vaginal probe. When the three follicles reach a diameter greater than 17 mm, the final maturation of the ovum will be performed with a single subcutaneous dose of 0.2 mg diphereline (GNRH agonist). After 12 hours The same drug will be repeated at a dose of 0.1 mg. Ovum pick up under vaginal ultrasound guidance will be performed 35 hours after the first dose under general anesthesia with a single lumen needle (Swemed, Vitrolife). Intervention 2: In intervention group 2 (S), on day 2 or 3 of the menstrual cycle, controlled ovarian stimulation with recombinant FSH (Gonal-f, merck senoro) at a dose of 175-112.5 IU / DAY will be performed for 4 days. FSH dose based on ovarian response and serum estradiol level It will be adjusted when the target follicle is more than 14 mm and the serum concentration of estradiol is more than 300 pg / ml. The antagonist-Ganirelix drug (Orgalutran, Organon) will be used at a subcutaneous dose of 0.25 mg / day. Follicle development will be monitored by transvaginal ultrasound with a 4-8 MHz vaginal probe. When the three follicles reach a diameter greater than 17 mm, the final maturation of the ovum will be performed with a single subcutaneous dose of 0.2 mg diphereline (GNRH agonist). Ovum pick up under vaginal ultrasound guidance will be performed 35 hours after the first dose under general anesthesia with a single lumen needle (Swemed, Vitrolife). Yes - There is a plan to make this available What will be shared: Statistical Results When: 6 month after the project completion To whom: By obtaining a license from the ethics committee and for scientific and research use in coordination with the main researchers Conditions: The data is for use in this design only. If necessary, after obtaining the necessary permits from the ethics committee Where to obtain: To researchers responsible for responding to this plan How to obtain: Written request Coordinated by the ethics committee 2 months Comments:
public Elham Askari
Department of Obstetrics and Gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 07134814336 +98 71 3233 2365 elliaskary_md@yahoo.com Shiraz University of Medical Sciences scientific Elham Askari
Department of Obstetrics and Gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
shiraz Iran (Islamic Republic of) 71348143360 +98 71 3233 2365 elliaskary_md@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Women with a definite diagnosis of endometriosis based on pathology report Aged between 21 and 35 years The first period of using Assisted reproductive technology (ART) method Normal serum Follicle stimulating hormone (FSH) concentration in primary follicular phase Anti mullerian hormone (AMH) more than 0.5, presence of both ovary Having the ART use indication that they are willing to participate in the study 21 years 35 years Female History of uterine and ovary surgery Poly cystic ovarian syndrome Triggering with Human chorionic gonadotropin (HCG) drug Severe fertilizing disorder in spouse Patient with hypo gonadotrpic hypogonadism and uterine abnormality N80.1 Endometriosis of ovary Treatment - Drugs Treatment - Drugs In intervention group 1 (D), on day 2 or 3 of the menstrual cycle, controlled ovarian stimulation with recombinant FSH (Gonal-f, merck senoro) at a dose of 175-112.5 IU / DAY will be performed for 4 days. FSH dose based on ovarian response and serum estradiol level It will be adjusted when the target follicle is more than 14 mm and the serum concentration of estradiol is more than 300 pg / ml. The antagonist-Ganirelix drug (Orgalutran, Organon) will be used at a subcutaneous dose of 0.25 mg / day. Follicle development will be monitored by transvaginal ultrasound with a 4-8 MHz vaginal probe. When the three follicles reach a diameter greater than 17 mm, the final maturation of the ovum will be performed with a single subcutaneous dose of 0.2 mg diphereline (GNRH agonist). After 12 hours The same drug will be repeated at a dose of 0.1 mg. Ovum pick up under vaginal ultrasound guidance will be performed 35 hours after the first dose under general anesthesia with a single lumen needle (Swemed, Vitrolife). In intervention group 2 (S), on day 2 or 3 of the menstrual cycle, controlled ovarian stimulation with recombinant FSH (Gonal-f, merck senoro) at a dose of 175-112.5 IU / DAY will be performed for 4 days. FSH dose based on ovarian response and serum estradiol level It will be adjusted when the target follicle is more than 14 mm and the serum concentration of estradiol is more than 300 pg / ml. The antagonist-Ganirelix drug (Orgalutran, Organon) will be used at a subcutaneous dose of 0.25 mg / day. Follicle development will be monitored by transvaginal ultrasound with a 4-8 MHz vaginal probe. When the three follicles reach a diameter greater than 17 mm, the final maturation of the ovum will be performed with a single subcutaneous dose of 0.2 mg diphereline (GNRH agonist). Ovum pick up under vaginal ultrasound guidance will be performed 35 hours after the first dose under general anesthesia with a single lumen needle (Swemed, Vitrolife). Oocyte maturation. Timepoint: Before and after treatment. Method of measurement: Transvaginal sonography. Oocyte yield. Timepoint: Before and after treatment. Method of measurement: Transvaginal sonography and hormonal assay. Shiraz University of Medical Sciences Approved 2022-09-11 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences, Zand St Shiraz Fars Iran (Islamic Republic of)