]>
IRCT20090526001952N15 IRCT 2021-05-22 Tehran University of Medical Sciences Comparison of the pregnancy outcomes in patients with the polycystic ovarian syndrome in two endometrial preparation method GnRHagonist plus hormone replacement therapy versus hormone replacement therapy frozen embryo transfer cycle Comparison of the pregnancy outcomes in patients with the polycystic ovarian syndrome in two endometrial preparation method GnRHagonist plus hormone replacement therapy versus hormone replacement therapy frozen embryo transfer cycle 2021-06-10 anticipated 124 Complete https://irct.ir/trial/55971 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization list will be prepared by a statistician using the block randomization method (using the site:www.sealedenvelope.com). Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained. Then the treatment will be performed based on the kind of treatment in the envelope, Blinding description: Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. 3 Infertility. Intervention 1: Intervention group:In the HRT group, from the second day of the cycle, he receives 2 mg of estradiol daily and this drug is increased to 6 mg per day in three days.Ten days later, they undergo vaginal ultrasound to check the thickness of the endometrium. If the thickness of the endometrium is greater than 8 mm, inject able progesterone is prescribed and the patient will be a candidate for FET transfer. If the thickness is less than 7 mm, it will be necessary to increase the dose of estradiol and continue treatment with it. The patient undergoes vaginal ultrasound every three days and if the desired thickness does not reach 21 days after the start of the cycle, the cycle will be canceled. Intervention 2: Intervention group:(Long GnRH agonist + HRT) From day 18-21 of the previous cycle, 0.5 cc of Superfect is injected daily and vaginal ultrasound is performed 10-14 days later If the endometrial thickness is less than 5 mm and there are no ovarian cysts, estradiol is started like HRT treatment and the agonist dose of GnRH starts with estradiol. It is halved (0.25 cc superfect) and superfect is prescribed until progesterone is started. At the time of progesterone administration, the administration of superfect is discontinued. Injections of estradiol and progesterone will be the same as for the HRT group. 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 It is not yet known if there will be a plan to make this available
public Ashraf Moini
Arash Hospital, Rashid Ave., Resalat Highway, Tehranpars, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3283 hosp_arash@tums.ac.ir Tehran University of Medical Sciences scientific Dr Ashraf Moini
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3195 hosp_arash@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) The first or second cycle of embryo transfer Normal uterine cavity PCO diagnosis based on Rotterdam criteria and correction (2018) Age 20 to 40 years 20 years 40 years Female Infertility with severe male factor endometriosis immunological disease FSH higher than 10 BMI greater than or equal to 30 Endometrial thickness on the day of transfer is less than 7 mm History of recurrent miscarriage N97.0 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs Intervention group:In the HRT group, from the second day of the cycle, he receives 2 mg of estradiol daily and this drug is increased to 6 mg per day in three days.Ten days later, they undergo vaginal ultrasound to check the thickness of the endometrium. If the thickness of the endometrium is greater than 8 mm, inject able progesterone is prescribed and the patient will be a candidate for FET transfer. If the thickness is less than 7 mm, it will be necessary to increase the dose of estradiol and continue treatment with it. The patient undergoes vaginal ultrasound every three days and if the desired thickness does not reach 21 days after the start of the cycle, the cycle will be canceled. Intervention group:(Long GnRH agonist + HRT) From day 18-21 of the previous cycle, 0.5 cc of Superfect is injected daily and vaginal ultrasound is performed 10-14 days later If the endometrial thickness is less than 5 mm and there are no ovarian cysts, estradiol is started like HRT treatment and the agonist dose of GnRH starts with estradiol. It is halved (0.25 cc superfect) and superfect is prescribed until progesterone is started. At the time of progesterone administration, the administration of superfect is discontinued. Injections of estradiol and progesterone will be the same as for the HRT group. Endometrial thickness. Timepoint: On the day of transfer. Method of measurement: transvaginal ultrasound. Chemical pregnancy. Timepoint: 14 days after transfer. Method of measurement: Beta HCG Test. Clinical pregnancy. Timepoint: 7 weeks of pregnancy. Method of measurement: Transvaginal Ultrasound. Ongoing pregnancy. Timepoint: 12 weeks of pregnancy. Method of measurement: Ultrasonography. Tehran University of Medical Sciences Approved 2021-04-27 Ethics committee of Tehran University of Medical Science Vice-Chancellor in Research, Tehran University of Medical Science,near Qods st, keshavarz blvd. Tehran Tehran Iran (Islamic Republic of)