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IRCT20200122046221N3 IRCT 2022-03-16 Jahrom University of Medical Sciences The comparison of efficacy and outcomes of Triptorelin (Diphereline®) and hCG in ovulation trigger in infertile women with poly cystic ovarian syndrome The comparison of efficacy and outcomes of Triptorelin (Diphereline®) and hCG in ovulation trigger in infertile women with poly cystic ovarian syndrome in IUI cycle: A randomize clinical trial study 2022-02-20 anticipated 120 Complete https://irct.ir/trial/61819 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, computerized block randomization (blocks size 3 and 9) will be performed, which is the randomization unit, individual and layers of randomization, age of people and randomization tools, table of random numbers. An independent clinical epidemiologist who is not involved in the study will use a randomized blockchain program (STATA14 software) to generate allocation codes. Random sequences will be placed in light-resistant envelopes and sealed. The research assistant will open sealed, numbered and opaque envelopes containing the assignment codes. Eligible participants, after signing the informed consent form, will be divided into two equal groups (hCG group and Diphereline group). 3 Infertility in women with Poly cystic ovarian syndrome. Intervention 1: Intervention group: Give two Letrozole tablets (2.5 mg) from Abureyhan Pharmaceutical Company, daily for 5 days for 3-7 days during only one menstrual cycle and then trans vaginal ultrasound on days 12-8 of the cycle to evaluate the thickness, endometrial pattern. After seeing at least one follicle of 18 mm or larger, inject two-tenths of a micro gram of Triptorelin (Diphereline) from the French company IPSEN and finally control women for pregnancy. Intervention 2: Control group: Give two tablets of Letrozole (2.5 mg) daily from Abu Reyhan Pharmaceutical Company, for 5 days during days 3-7 during only one menstrual cycle and then transvaginal ultrasound on days 12-8 of the cycle to evaluate the thickness, endometrial pattern. After seeing at least one follicle 18 mm or larger, inject hCG 10000Iu injection from the German company FERRING and finally control the women in terms of pregnancy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Athar Rasekhjahromi
Jahrom-Ostad Motahari Street Jahrom University of Medical Sciences
Jahrom Iran (Islamic Republic of) ۷۴۱۴۸-۴۶۱۹۹ +98 71 5433 1521 A.rasekh@jums.ac.ir Jahrom University of Medical Sciences scientific Athar Rasekhjahromi
Jahrom, Motahari Blv
Jahrom Iran (Islamic Republic of) 7414846199 +98 71 5426 6602 drrasekh@yahoo.com Jahrom University of Medical Sciences Iran (Islamic Republic of) Infertile women who do not become pregnant one year after cohabitation and intercourse without the use of contraceptives From 15 years old to 45 years old With Poly cystic ovarian syndrome 15 years 45 years Female Semen analysis and abnormal hysterosalpingography Over 45 years old Myoma Hyperprolactinemia Hypothyroidism Hyperthyroidism FSH> 12 Women with endometriosis History of contact with any substance induced by previous ovulation Kidney and liver disease Any contraindications to Diphereline and hCG Male factor E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Give two Letrozole tablets (2.5 mg) from Abureyhan Pharmaceutical Company, daily for 5 days for 3-7 days during only one menstrual cycle and then trans vaginal ultrasound on days 12-8 of the cycle to evaluate the thickness, endometrial pattern. After seeing at least one follicle of 18 mm or larger, inject two-tenths of a micro gram of Triptorelin (Diphereline) from the French company IPSEN and finally control women for pregnancy. Control group: Give two tablets of Letrozole (2.5 mg) daily from Abu Reyhan Pharmaceutical Company, for 5 days during days 3-7 during only one menstrual cycle and then transvaginal ultrasound on days 12-8 of the cycle to evaluate the thickness, endometrial pattern. After seeing at least one follicle 18 mm or larger, inject hCG 10000Iu injection from the German company FERRING and finally control the women in terms of pregnancy. Pregnancy. Timepoint: End of menstrual cycle. Method of measurement: Serum b-hCG. Incidence of ovarian hyperstimulation syndrome. Timepoint: End of menstrual cycle. Method of measurement: Clinical signs and ultrasound. Incidence of multiple birth. Timepoint: End of menstrual cycle. Method of measurement: ultrasound sonography. Jahrom University of Medical Sciences Approved 2022-02-05 Ethics committee of Jahrom University of Medical Sciences Motahari Blvd Jahrom Fars Iran (Islamic Republic of)