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IRCT20120104008611N12 IRCT 2021-03-19 Tehran University of Medical Sciences Assessment the effect of combining letrozole and gonadotropin on the IVF / ICSI cycle success rate Comparison the effect of combining letrozole and gonadotropin with gonadotropin alone on the IVF / ICSI cycle success rate in women with endometriosis 2021-04-04 anticipated 94 Complete https://irct.ir/trial/54384 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule: First, 47 letters A and 47 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (letrozole) or B (clomiphene) are determined by a lot, Blinding description: This study is performed double-blind, the participants, and the analyzer do not know the type of treatment. The participants, because of placebo usage, do not know the type of their treatment. Also, the analyzer does not know about the treatment group codes in the SPSS datasheet. 3 Endometriosis. Intervention 1: Intervention group: On the third day of menstruation, all participants will be evaluated with TVS for measuring endometrial thickness and antral follicle counts. Then, the GnRH agonist will be prescribed and HMG will be initiated when the follicle diameters reach 10 to 12 mm. Their usage will be continued until the ovulation-triggering day, rHCG will be prescribed as a triggering drug when at least two follicles were ≥ 18 mm, and serum E2 ≥ will be 500 pg/mL. On the third day of menstruation, the intervention group will receive letrozole 5 mg orally per day for up to 5 days. Intervention 2: Control group: On the third day of menstruation, all participants will be evaluated with TVS for measuring endometrial thickness and antral follicle counts. Then, the GnRH agonist will be prescribed and HMG will be initiated when the follicle diameters reach 10 to 12 mm. Their usage will be continued until the ovulation-triggering day, rHCG will be prescribed as a triggering drug when at least two follicles were ≥ 18 mm, and serum E2 ≥ will be 500 pg/mL. On the third day of menstruation, the control group will receive a placebo orally per day for up to 5 days. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants When: After manuscript published To whom: No limitations Conditions: The data is only available to the project manager, Dr. Pakniat, and any analysis must be done with her opinion. Where to obtain: Dr. Pakniat How to obtain: Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Pakniat. Comments:
public Hamideh Pakniat
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8608 9089 pakniat110@yahoo.com Tehran University of Medical Sciences scientific Hamideh Pakniat
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8608 9089 pakniat110@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Women with 18 to 35 year-old Body mass index lower than 30 kg/m2 In her first IVF cycle Without any uterine diseases Sperm motility of at least 20% in sperm analysis Anti-mullerin hormone greater than 1 ng/ml 18 years 35 years Female Women who underwent letrozole or clomiphene therapy for induction ovulation Sever endometriosis with DIE Submucosal myoma with any size and intramural myoma greater than 3 cm was detected in transvaginal ultrasound Withdraw to participation N80.9 Endometriosis, unspecified Treatment - Drugs Treatment - Drugs Intervention group: On the third day of menstruation, all participants will be evaluated with TVS for measuring endometrial thickness and antral follicle counts. Then, the GnRH agonist will be prescribed and HMG will be initiated when the follicle diameters reach 10 to 12 mm. Their usage will be continued until the ovulation-triggering day, rHCG will be prescribed as a triggering drug when at least two follicles were ≥ 18 mm, and serum E2 ≥ will be 500 pg/mL. On the third day of menstruation, the intervention group will receive letrozole 5 mg orally per day for up to 5 days. Control group: On the third day of menstruation, all participants will be evaluated with TVS for measuring endometrial thickness and antral follicle counts. Then, the GnRH agonist will be prescribed and HMG will be initiated when the follicle diameters reach 10 to 12 mm. Their usage will be continued until the ovulation-triggering day, rHCG will be prescribed as a triggering drug when at least two follicles were ≥ 18 mm, and serum E2 ≥ will be 500 pg/mL. On the third day of menstruation, the control group will receive a placebo orally per day for up to 5 days. The total prescribed dosage of Cinnal-f, and HMG. Timepoint: Once, at the trigger day. Method of measurement: Will be calculated by gynecologic. The estradiol level. Timepoint: Once, at the trigger day. Method of measurement: Blood sample. The oocyte number, and quality. Timepoint: Once, at puncture day. Method of measurement: According to the oocyte puberty degree, the oocyte quality will be determined. The embryo quality. Timepoint: Once, after in vitro fertilization. Method of measurement: According to Gardner system. Biochemical pregnancy. Timepoint: Once, 14 days after fetus transfer. Method of measurement: Blood sampling. Clinical pregnancy. Timepoint: Once, 6 to 8 weeks after fetus transfer. Method of measurement: Pregnancy sac observation in transvaginal ultrasound. Tehran University of Medical Sciences Approved 2021-01-23 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St Tehran Tehran Iran (Islamic Republic of)