]>
IRCT20200421047152N5 IRCT 2023-11-25 Iranian academic center for education culture and research The effect of oral dydrogesterone in supporting the luteal phase in patients undergoing in vitro fertilization treatment Comparison of the effect of oral dydrogesterone with intramuscular progesterone in supporting the luteal phase in patients undergoing in vitro fertilization treatment, a non-inferiority clinical trial 2023-11-22 anticipated 384 Complete https://irct.ir/trial/73748 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Interim analysis will be done after the entry of 200th people with the aim of primary outcome assessment and recalculation of the sample size, Randomization description: After obtaining informed consent, the patients were randomized and divided into two groups of 192 people pretreated with oral dydrogesterone and the other group with progesterone ampoules using permuted block randomization with size of blocks of four by Sealedenvelope.com website software. To conceal the sequence of randomization, it will be given to an independent third person, and the code will be given to the investigator one by one, Blinding description: Since the study outcome will be assessed by someone other than the health care giver, the evaluator records the outcome information without knowing the type of intervention. 3 Infertility treated by in Vitro Fertilization. Intervention 1: Control group: the enrolled patients enter a cycle of 45 days. In this group, the LD pill starts from the third day of menstruation and continues, and on the 21st day of the cycle, Laurelin 1.87 mg ampoule is injected.Then estradiol 2 mg every 8 hours is started on the third day of the next menstrual cycle, and ultrasound is performed 7 to 10 days later. If the thickness of the endometrium is more than 7 mm, progesterone ampoule 50 mg (Fomogex-IH) intramuscularly is prescribed every day to achieve the transformation of the endometrium. In the next stage, embryo transfer is done after 5 days (blastocyst stage embryo) will be done. In women less than 30 years old, one embryo will be transferred, and in women between 30 and 40 years old, two blast embryos will be transferred. Intervention 2: Intervention group:the enrolled patients enter a cycle of 45 days. In this group, the LD pill starts from the third day of menstruation and continues, and on the 21st day of the cycle, Laurelin 1.87 mg ampoule is injected.Then estradiol 2 mg every 8 hours is started on the third day of the next menstrual cycle, and ultrasound is performed 7 to 10 days later. If the thickness of the endometrium is more than 7 mm, then oral dydrogesterone 10 mg three times a day will be prescribed. In the next stage, embryo transfer is done after 5 days (blastocyst stage embryo) will be done. In women less than 30 years old, one embryo will be transferred, and in women between 30 and 40 years old, two blast embryos will be transferred. 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 No further information
public Somayeh Saleki
Yakhchal Junction , Shariati st.
Tehran Iran (Islamic Republic of) 1941913114 +98 21 23519 dr.somayeh.saleki2@gmail.com Iranian academic center for education culture and research scientific Afsaneh Mohammadzadeh
Yakhchal Junction , Shariati st.
Tehran Iran (Islamic Republic of) 1941913114 +98 21 23519 af85af@yahoo.com Iranian academic center for education culture and research Iran (Islamic Republic of) Women between 20-40 years old with a 5-day frozen embryo created by intracytoplasmic sperm injection (ICSI) Normal uterine cavity 20 years 40 years Female Follicle stimulating hormone serum level above 12 FSH milliunits/ml History of endometriosis History of moderate to severe adenomyosis History of 3 or more previously failed embryo transfers Sex selection cycles Embryo donation cycles or surrogacy Hydrosalpinx Any type of uterine abnormalities (septum, etc.) Submucousal myoma Asherman syndrome Z31.2 In vitro fertilization Treatment - Drugs Treatment - Drugs Control group: the enrolled patients enter a cycle of 45 days. In this group, the LD pill starts from the third day of menstruation and continues, and on the 21st day of the cycle, Laurelin 1.87 mg ampoule is injected.Then estradiol 2 mg every 8 hours is started on the third day of the next menstrual cycle, and ultrasound is performed 7 to 10 days later. If the thickness of the endometrium is more than 7 mm, progesterone ampoule 50 mg (Fomogex-IH) intramuscularly is prescribed every day to achieve the transformation of the endometrium. In the next stage, embryo transfer is done after 5 days (blastocyst stage embryo) will be done. In women less than 30 years old, one embryo will be transferred, and in women between 30 and 40 years old, two blast embryos will be transferred. Intervention group:the enrolled patients enter a cycle of 45 days. In this group, the LD pill starts from the third day of menstruation and continues, and on the 21st day of the cycle, Laurelin 1.87 mg ampoule is injected.Then estradiol 2 mg every 8 hours is started on the third day of the next menstrual cycle, and ultrasound is performed 7 to 10 days later. If the thickness of the endometrium is more than 7 mm, then oral dydrogesterone 10 mg three times a day will be prescribed. In the next stage, embryo transfer is done after 5 days (blastocyst stage embryo) will be done. In women less than 30 years old, one embryo will be transferred, and in women between 30 and 40 years old, two blast embryos will be transferred. Clinical pregnancy. Timepoint: 5 weeks after embryo transfer. Method of measurement: Trans vaginal ultrasound imaging. Chemical pregnancy. Timepoint: Day 14 after embryo transfer. Method of measurement: Serum levels of beta human chorionic gonadotropin hormone (Beta HCG). Ongoing pregnancy. Timepoint: 12 weeks after embryo transfer. Method of measurement: Trans abdominal ultrasound imaging. Iranian academic center for education culture and research Approved 2023-11-11 Ethical commitee of Avicenna Reserch Institute,ACECR affiliated research institute in biotechnology Daneshjou Blvrd. Evin. Chamran Exp.way Tehran Tehran Iran (Islamic Republic of)