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IRCT20150105020558N3 IRCT 2021-03-02 Tehran University of Medical Sciences Letrozole effect in IVF cycles Comparison of the Effectiveness of Letrozole with Estradiol on Frozen Embryo Transfer Cycle Outcomes in Women with Polycystic Ovarian Syndrome 2021-04-21 anticipated 510 Complete https://irct.ir/trial/53313 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation, there are 255 small envelopes containing letter A and 255 small envelopes in the same shape containing letter B in a bag; and for each patient one envelope is selected randomly, Blinding description: Whilst the patients, the sonographer and the physician who will be responsible for administration of drugs will know about the interventions; the physician who will be responsible for embryo transferring and the statistician are unaware of the interventions. 3 Polycystic ovarian syndrome. Intervention 1: Intervention group: In this group, two letrozole tablets (2.5 mg, َAburaihan pharmaceutical co) is prescribed orally for 5 days initiating on day 3 of spontaneous menses or progesterone-induced withdrawal bleeding. Ultrasound monitoring are performed from cycle day 10 onwards. if the leading follicle reaches a mean diameter of ≥ 14mm on cycle day 10, ultrasound is repeated every 2 days. In case of a mean dominant follicle diameter < 14mm on day 10, a daily dosage of 75 IU hMG is supplemented to stimulate follicle growth. When the dominant follicle reaches a mean diameter of ≥17mm and endometrial thickness reaches ≥ 7mm, a bolus of urinary hCG 5000 IU will be injected. According to embryo staging (cleavage stage or blastocyst), embryo transferring will be scheduled 4 or 6 days later. Intervention 2: Control group: In this group, three Estradiol Valerate tablets (2 mg, َAburaihan pharmaceutical co) are prescribed orally from day 3 of spontaneous menses or progesterone-induced withdrawal bleeding. Ultrasound monitoring are performed 12 to 14 days later. ultrasound examination is carried out to measure endometrial thickness as well as to ensure there is no dominant follicle. When the endometrial thickness attained ≥ 7mm, progestrone vaginal suppositories (Fertigest, 400mg, Aburaihan pharmaceutical co) twice daily are initiated. According to embryo staging (cleavage stage or blastocyst), embryo transferring will be scheduled 4 or 6 days later. Yes - There is a plan to make this available What will be shared: Project report to Deputy of Research of TUMS, every researcher who needs data for research When: 5 years To whom: Deputy of Research of TUMS, every researcher who needs data for research. Conditions: After final report and publishing the results Where to obtain: Miss Moamaei-Deputy of Research of TUMS,fifth floor,Central building of TUMS,Ghods ave., Tel:00982164431 How to obtain: Miss Moamaei-Deputy of Research of TUMS or send the request to maeb214@yahoo.com, responsible author, after one month they will be responded Comments:
public Mahbod Ebrahimi
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0000 maeb214@yahoo.com Tehran University of Medical Sciences scientific Mahbod Ebrahimi
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 4216 0000 maeb214@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) The patients with impression of polycystic ovarian syndrome according to Rotterdam consensus as fulfilling at least two of the three criteria: 1- oligo/anovulation; 2- clinical or biochemical signs of hyperandrogenism; and 3- polycystic ovarian morphology on ultrasound Female age: 18 - 40 years old The candidate of frozen embryo transfer 18 years 40 years Female The other causes of hyperandrogenism and ovarian dysfunction Basal FSH level >10 IU/L History of recurrent miscarriage History of congenital or acquired uterine malformations History of male factor infertility E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: In this group, two letrozole tablets (2.5 mg, َAburaihan pharmaceutical co) is prescribed orally for 5 days initiating on day 3 of spontaneous menses or progesterone-induced withdrawal bleeding. Ultrasound monitoring are performed from cycle day 10 onwards. if the leading follicle reaches a mean diameter of ≥ 14mm on cycle day 10, ultrasound is repeated every 2 days. In case of a mean dominant follicle diameter < 14mm on day 10, a daily dosage of 75 IU hMG is supplemented to stimulate follicle growth. When the dominant follicle reaches a mean diameter of ≥17mm and endometrial thickness reaches ≥ 7mm, a bolus of urinary hCG 5000 IU will be injected. According to embryo staging (cleavage stage or blastocyst), embryo transferring will be scheduled 4 or 6 days later. Control group: In this group, three Estradiol Valerate tablets (2 mg, َAburaihan pharmaceutical co) are prescribed orally from day 3 of spontaneous menses or progesterone-induced withdrawal bleeding. Ultrasound monitoring are performed 12 to 14 days later. ultrasound examination is carried out to measure endometrial thickness as well as to ensure there is no dominant follicle. When the endometrial thickness attained ≥ 7mm, progestrone vaginal suppositories (Fertigest, 400mg, Aburaihan pharmaceutical co) twice daily are initiated. According to embryo staging (cleavage stage or blastocyst), embryo transferring will be scheduled 4 or 6 days later. Live Birth Rate. Timepoint: After pregnancy termination. Method of measurement: The number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers. Clinical Pregnancy Rate. Timepoint: 4 to 6 weeks after frozen embryo transfer. Method of measurement: A visible gestational sac by transvaginal ultrasound. Ongoing Pregnancy Rate. Timepoint: After 20th weeks of pregnancy. Method of measurement: The number of fetuses with heart activity beyond 20 weeks of gestation. Cycle cancellation rate. Timepoint: from 15th until 21th days of cycle. Method of measurement: The number of cancelled cycles. Endometrial thickness. Timepoint: On the day of HCG injection. Method of measurement: The measuring of endometrial thickness by transvaginal ultrasound. Abortion rate. Timepoint: From 5th until 24th gestational weeks. Method of measurement: The detection of lack or loss of fetal heart activity by ultrasound. Premature delivery rate. Timepoint: From 25th until 36th gestational weeks. Method of measurement: The delivery of fetus(es). Tehran University of Medical Sciences Approved 2020-12-14 Ethics committee of Sina Hospital Yas Complex Hospital, Forth Alley Corner, North Ostad Nejatollahi Avenue, Karimkhan Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)