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IRCT20220702055335N3 IRCT 2023-10-17 Vice chancellor for Research,Tabriz University Of Medical Sciences Evaluating the role of hysteroscopy in the success of In vitro fertilization (IVF) Evaluating the role of hysteroscopy in the success of in vitro fertilization (IVF) 2023-10-17 anticipated 130 Complete https://irct.ir/trial/70790 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: People will be allocated to two intervention and control groups by the method of balanced block randomization.The number of blocks is 33 and the volume inside each block is 4. The order in which the participants enter the study groups determines the order within each group. N/A Female infertility. Intervention 1: In the intervention group, 1 to 3 months before the start of IVF, hysteroscopy is first performed by a surgeon in the early to mid-follicular phase of the menstrual cycle.Ovulation stimulation is done with Letrozole, Sinal F, hMG and Sterotide. When at least two to three follicles of 18 mm are seen in the ultrasound, the release of eggs is done by decapeptyl and hCG.At most one or two cycles after ovulation, from the second day of the menstrual cycle, the preparation of the endometrium for embryo transfer is done using HRT and estrogen and progesterone, and a maximum of 2 to 3 3-day-old embryos (cleavage) are transferred as Freez.The luteal phase is supported with progesterone ampoules and suppositories until the end of the first trimester. Intervention 2: In the control group, two 2.5 mg letrozole tablets are given daily from the third day of menstruation until the day of hCG injection. From the third day of starting letrozole, 150 to 300 units of Sinal F ampoules are given daily until the day of hCG injection.From the second day of SinalF injection, one or two hMG is given daily until the day of hCG injection, and when the first follicle reaches 14 mm in size, one Sterotide 250 is given daily.When at least 2 to 3 18 mm follicles are detected in ultrasound, egg release is done by 10,000 units of Hcg and two ampoules of 0.1 decapeptyl, and 36 hours later, ovulation is done by vaginal ultrasound.At most one to two cycles after the second day of the menstrual cycle, 6 mg of estradiol per day is started for the patient, and when the endometrial thickness reaches at least 7 to 8 mm, 50-100 mg of intramuscular progesterone is given to the patient for 4 days. It will be given and on the fourth day of progesterone injection, transfer of 2 to 3 three-day-old embryos (cleavage) is performed for the patient.Luteal phase support is done until the end of the third month with progesterone 50mg ampoules every other day and progesterone 400 suppositories every 12 hours. 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 After the completion of the project, the decision will be made.
public Dr. Parvin Hakimi
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3551 9161 lahroudin@gmail.com Tabriz University of Medical Sciences scientific Dr. Parvin Hakimi
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 35519161 lahroudin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Primary infertility Age below 40 years Body mass index between 19 and 35 kg/m2 Couples who have not had any identifiable reason for infertility after one year of infertility investigation Hysterosalpingography based on open uterine tubes The number of antral follicles, bigger and equal 5 no limit 40 years Female Azoospermia The History of Surgical Treatment of Endometrial History of in vitro fertilisation N97.9 Female infertility, unspecified Treatment - Surgery Treatment - Drugs In the intervention group, 1 to 3 months before the start of IVF, hysteroscopy is first performed by a surgeon in the early to mid-follicular phase of the menstrual cycle.Ovulation stimulation is done with Letrozole, Sinal F, hMG and Sterotide. When at least two to three follicles of 18 mm are seen in the ultrasound, the release of eggs is done by decapeptyl and hCG.At most one or two cycles after ovulation, from the second day of the menstrual cycle, the preparation of the endometrium for embryo transfer is done using HRT and estrogen and progesterone, and a maximum of 2 to 3 3-day-old embryos (cleavage) are transferred as Freez.The luteal phase is supported with progesterone ampoules and suppositories until the end of the first trimester In the control group, two 2.5 mg letrozole tablets are given daily from the third day of menstruation until the day of hCG injection. From the third day of starting letrozole, 150 to 300 units of Sinal F ampoules are given daily until the day of hCG injection.From the second day of SinalF injection, one or two hMG is given daily until the day of hCG injection, and when the first follicle reaches 14 mm in size, one Sterotide 250 is given daily.When at least 2 to 3 18 mm follicles are detected in ultrasound, egg release is done by 10,000 units of Hcg and two ampoules of 0.1 decapeptyl, and 36 hours later, ovulation is done by vaginal ultrasound.At most one to two cycles after the second day of the menstrual cycle, 6 mg of estradiol per day is started for the patient, and when the endometrial thickness reaches at least 7 to 8 mm, 50-100 mg of intramuscular progesterone is given to the patient for 4 days. It will be given and on the fourth day of progesterone injection, transfer of 2 to 3 three-day-old embryos (cleavage) is performed for the patient.Luteal phase support is done until the end of the third month with progesterone 50mg ampoules every other day and progesterone 400 suppositories every 12 hours. Chemical pregnancy rate. Timepoint: Two week after transfer. Method of measurement: BHCG≥200. Clinical pregnancy rate. Timepoint: Two week after transfer. Method of measurement: Observation of pregnancy sac and Fetal Heart in ultrasonography. Rate of abortion. Timepoint: Until the 20th week of pregnancy. Method of measurement: The observation of bleeding. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2023-10-02 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)