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IRCT20090526001952N12 IRCT 2020-03-30 Tehran University of Medical Sciences Comparison of two endometrial preparation protocols for frozen-thawed embryo transfer in polycystic ovarian syndrome Comparison of Hormone replacement therapy with mild ovarian stimulation as endometrial preparation protocols for frozen-thawed embryo transfer in polycystic ovarian syndrome 2018-09-23 anticipated 120 Complete https://irct.ir/trial/45519 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In the present study, the gynecologist (fellowship in infertility) and an attending physician (also gynecologist - assistant professor) will be aware of the treatment. Although the patient has been already informed about the study and the treatment arms; however, she will not know about the treatment she received. 3 Polycystic ovarian syndrome. Intervention 1: Intervention group 1: This group will be received estradiol valerate (Aboureihan Co.). On day 3 after LMP, estradiol valerate is administered at the dose of 4 mg and will be increased after 3 days to 6 mg. The patient will be examined after a week. An endometrial thickness of 8 mm or more is optimum for progesterone administration (Cyclogest, Actoverco), otherwise the dose of estradiol will be increased up to 8 mg. If the optimal endometrial thickness is not achieved after 20 days, embryo transfer will be canceled. Intervention 2: Intervention group 2: Patients will receive letrozole (Femara, Novartis; 2.5 mg, b.i.d.) on day 3 after LMP for 5 days. Afterward treatment with HMG (Karma Co.; 75-150 mg, daily) on day 5 - 9 after LMP. Endometrial thickness, follicle size, and LH serum levels are measured frequently and in case of follicle size of 12-13 mm, an LH measurement will be done on next visit. Transvaginal ultrasound will be performed every 3 days, while hormon therapy is continued. An endometrial thickness of 8 mm or more or a follicle size of 20 mm or more is good for HCG (Ronak Daru; 5000 - 10000 IU) administration for ovulation induction. On day 20th, if endometrial Thickness was less than 7 mm the transfer cycle will be canceled regardless of follicle condition. Yes - There is a plan to make this available What will be shared: Information regarding main consequence When: 6 months after paper publication To whom: Researchers in academic institutes Conditions: Systematic review and metaanalysis Where to obtain: Dr. Ashraf Moini, Arash Women Hospital, 1653915981, Tehran, Iran Email: hosp_arash@tums.ac.ir How to obtain: Sending request to principle investigator Comments:
public Dr. Azadeh Hosseini
Baghdarnia St.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3283 ahosseini11@gmail.com Tehran University of Medical Sciences scientific 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 Iran (Islamic Republic of) Iran (Islamic Republic of) Age 20- 35 Years First or second cycle of embryo transfer Normal uterine cavity 20 years 35 years Female Severe male factor Patients with pregestational diagnosis Severe endometriosis Concomitant immunologic disease Follicle stimulating hormone more than 10 IU Body mass index equal or more than 30 E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group 1: This group will be received estradiol valerate (Aboureihan Co.). On day 3 after LMP, estradiol valerate is administered at the dose of 4 mg and will be increased after 3 days to 6 mg. The patient will be examined after a week. An endometrial thickness of 8 mm or more is optimum for progesterone administration (Cyclogest, Actoverco), otherwise the dose of estradiol will be increased up to 8 mg. If the optimal endometrial thickness is not achieved after 20 days, embryo transfer will be canceled. Intervention group 2: Patients will receive letrozole (Femara, Novartis; 2.5 mg, b.i.d.) on day 3 after LMP for 5 days. Afterward treatment with HMG (Karma Co.; 75-150 mg, daily) on day 5 - 9 after LMP. Endometrial thickness, follicle size, and LH serum levels are measured frequently and in case of follicle size of 12-13 mm, an LH measurement will be done on next visit. Transvaginal ultrasound will be performed every 3 days, while hormon therapy is continued. An endometrial thickness of 8 mm or more or a follicle size of 20 mm or more is good for HCG (Ronak Daru; 5000 - 10000 IU) administration for ovulation induction. On day 20th, if endometrial Thickness was less than 7 mm the transfer cycle will be canceled regardless of follicle condition. Number (ratio) of successful pregnancy. Timepoint: 40 weeks after study initiation. Method of measurement: Medical examination and ultrasound. Tehran University of Medical Sciences Approved 2020-01-29 Ethics Committee of Tehran University of Medical Sciences Baghdarnia St. Tehran Tehran Iran (Islamic Republic of)