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IRCT20200601047630N1 IRCT 2020-09-18 Tehran University of Medical Sciences The effect of progesterone in preventing LH surge in IVF cycles Comparison of progesterone effect in preventing LH surge and quality of oocytes and embryos in IVF cycles with patients undergoing antagonist cycle in Shariati Hospital during 97-98 2018-03-21 anticipated 120 Complete https://irct.ir/trial/48593 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, all patients who meet the inclusion criteria are entered into an Excel column, and then using the Rand option in this software, in the opposite column, each patient is randomly assigned the number 1 or 2. No. 1: Intervention group and No. 2: control group. 1-2 Infertility. Intervention 1: Intervention group: On day 2-3 of the gonadotropin cycle, including FSH with or without HMG, with medroxyprogesterone 5 mg daily, two doses are given. Vaginal ultrasounds were performed on days 9 to 10, and if 18 to 20 mm follicles were found, HCG was injected for ovulation. Then, 36 hours later, the puncture was performed. If the follicle was less than 18 mm, the Continuation of gonadotropin is done with an additional dose and medroxyprogesterone and ultrasound on the 12th day, and again if on the ultrasound of the 12th day the follicle was 18 to 20 mm, HCG is injected. If the follicle is less than 18 mm, gonadotropin and medroxyprogesterone are continued and then ultrasound is performed on day 14 and a decision is made accordingly. This process continues until day 25 of the cycle and until the follicle responds to treatment, until the day of HCG injection. And medroxyprogesterone is given and medroxyprogesterone is discontinued on the day of HCG injection. Intervention 2: Control group: In the control group, 2 to 3 cycles of gonadotropin, including FSH with or without HMG, are given on day 3, then one week later, vaginal ultrasound is performed. If the follicle is between 18 and 20 mm, HCG is injected for ovulation and then a puncture for IVF is performed 36 hours later. If the follicle is larger than 14 mm, asteroid (gonadotropin antagonist) is given with gonadotropin, and ultrasound is done again on the 12th day. If the follicle is less than 14 mm, the gonadotropin is continued with a double dose and the ultrasound is repeated on the 12th day. On day 12 ultrasound, if an 18 to 20 mm follicle is found, HCG is injected for ovulation and then a puncture is performed 36 hours later.If a 14 mm follicle is found on the ultrasound on day 12, the steroid is started, along with continued gonadotropin, and on day 14 sonography will be done again. If the follicle was less than 14 mm on day 12, the gonadotropin will be continued with an overdose, and on day 14, an ultrasound will be performed, and a decision will be made based on the sonography on day 14. This process can continue until the 25th day of the cycle, ie until the follicle responds to the drug. And patients are excluded from the study when they have a follicle less than 8 mm at the beginning, in fact, 14 mm follicle is the time of onset of steroid and follicle 18 to 20 mm is the time of onset of HCG and continues until the day of HCG gonadotropin and steroid injection. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as information about the main consequence or the like, can be shared When: Start the access period 6 months after printing the results To whom: Data will only be available to researchers working at academic and scientific institutions Conditions: For research only Where to obtain: the email of Dr. Pouri How to obtain: Apply via email and specify the purpose of using the data Comments:
public Sara Pouri
Jalal highway
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 Sarapouri65@gmail.com Tehran University of Medical Sciences scientific Ayda Najafian
Jalal highway
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 anajafian@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) The age between 18 and 35 years ,, a normal sperm test a normal body mass index (18-30 kg / m2) the presence of both ovaries and the opening of the tubes 18 years 35 years Female Tubal factor severe endometriosis hypothalamic amenorrhea oligoasthenospermia (abnormal sperm count and shape) severe uterine anomalies N97.9 Female infertility, unspecified Treatment - Drugs Treatment - Drugs Intervention group: On day 2-3 of the gonadotropin cycle, including FSH with or without HMG, with medroxyprogesterone 5 mg daily, two doses are given. Vaginal ultrasounds were performed on days 9 to 10, and if 18 to 20 mm follicles were found, HCG was injected for ovulation. Then, 36 hours later, the puncture was performed. If the follicle was less than 18 mm, the Continuation of gonadotropin is done with an additional dose and medroxyprogesterone and ultrasound on the 12th day, and again if on the ultrasound of the 12th day the follicle was 18 to 20 mm, HCG is injected. If the follicle is less than 18 mm, gonadotropin and medroxyprogesterone are continued and then ultrasound is performed on day 14 and a decision is made accordingly. This process continues until day 25 of the cycle and until the follicle responds to treatment, until the day of HCG injection. And medroxyprogesterone is given and medroxyprogesterone is discontinued on the day of HCG injection. Control group: In the control group, 2 to 3 cycles of gonadotropin, including FSH with or without HMG, are given on day 3, then one week later, vaginal ultrasound is performed. If the follicle is between 18 and 20 mm, HCG is injected for ovulation and then a puncture for IVF is performed 36 hours later. If the follicle is larger than 14 mm, asteroid (gonadotropin antagonist) is given with gonadotropin, and ultrasound is done again on the 12th day. If the follicle is less than 14 mm, the gonadotropin is continued with a double dose and the ultrasound is repeated on the 12th day. On day 12 ultrasound, if an 18 to 20 mm follicle is found, HCG is injected for ovulation and then a puncture is performed 36 hours later.If a 14 mm follicle is found on the ultrasound on day 12, the steroid is started, along with continued gonadotropin, and on day 14 sonography will be done again. If the follicle was less than 14 mm on day 12, the gonadotropin will be continued with an overdose, and on day 14, an ultrasound will be performed, and a decision will be made based on the sonography on day 14. This process can continue until the 25th day of the cycle, ie until the follicle responds to the drug. And patients are excluded from the study when they have a follicle less than 8 mm at the beginning, in fact, 14 mm follicle is the time of onset of steroid and follicle 18 to 20 mm is the time of onset of HCG and continues until the day of HCG gonadotropin and steroid injection. LH surge. Timepoint: End of pregnancy. Method of measurement: blood tests. Quality of oocyte. Timepoint: End of pregnancy. Method of measurement: Blood tests. Quality of embryo. Timepoint: End of pregnancy. Method of measurement: Blood tests. Clinical pregnancy. Timepoint: Day 25 of cycle. Method of measurement: Blood analysis. Tehran University of Medical Sciences Approved 2020-05-04 Ethics committee of Tehran University of Medical Sciences Qods st. TUMS Tehran Tehran Iran (Islamic Republic of)