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IRCT20080831001141N27 IRCT 2020-11-22 ROYAN Institute Endometrial preparation for frozen-thawed embryo transfer in patients with polycystic ovarian syndrome FET-PCOS Endometrial preparation with or without gonadotropin-releasing hormone agonist for frozen-thawed embryo transfer in patients with polycystic ovarian syndrome 2017-08-20 anticipated 212 Complete https://irct.ir/trial/52132 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 6. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 212 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope. N/A Polycystic ovarian syndrome. Intervention 1: Intervention group: The group of endometrial preparation with gonadotropin-releasing hormone agonist. In this group, the endometrium of patients for embryo transfer will be prepared through the standard protocol using a gonadotropin-releasing hormone agonist. This group has pituitary suppression prior to steroid hormone administration. Pituitary suppression in patients will be performed using 500 micro-gram suprefact (Buserelin, Sanofi Aventis, Germany) injection per day subcutaneously from day 17 of the menstrual and continued it for 14 days. Then, the dose of suprefact was reduced to 200 micro-gram per day, and the endometrium will be prepared through daily administration of 6 mg of estradiol valerate tablets (Abouryhan Pharmacy Company, Tehran, Iran) for 12 days. When endometrial thickness reached 8 mm or more, 50 mg intramuscular progesterone (Abouryhan Pharmacy Company, Tehran, Iran) daily will be commenced, and suprefact will be stopped. Embryo transfer will be performed at 48±3 hours after progesterone injection for two day embryos and 72±3 hours after progesterone injection for three day embryos. Intervention 2: Control group: The group of endometrial preparation without gonadotropin-releasing hormone agonist. In this group, the endometrium of patients for embryo transfer will be prepared through the standard protocol using steroid hormone administration without gonadotropin-releasing hormone agonist. This group begins steroid supplementation without prior pituitary desensitization. The endometrium will be prepared through daily administration of 6 mg of estradiol valerate tablets (Abouryhan Pharmacy Company, Tehran, Iran) for 12 days. When endometrial thickness reached 8 mm or more, 50 mg intramuscular progesterone (Abouryhan Pharmacy Company, Tehran, Iran) daily will be commenced. Embryo transfer will be performed at 48±3 hours after progesterone injection for two day embryos and 72±3 hours after progesterone injection for three day embryos. Yes - There is a plan to make this available What will be shared: Clinical study report (published article) When: After the publication of the article To whom: Available to the public. Conditions: Scientific use by citing the source. Where to obtain: Dr. Firehouse Ghaffari Email: ghafaryf@yahoo.com How to obtain: Request via e-mail Comments:
public Firouzeh Ghaffari
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 ghafaryf@yahoo.com ROYAN Institute scientific Firouzeh Ghaffari
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 ghafaryf@yahoo.com ROYAN Institute Iran (Islamic Republic of) Infertile women with polycystic ovarian syndrome based on Rotterdam criteria Age 20-37 years 20 years 37 years Female Women with hematologic and autoimmune disorders Couples with chromosomal and genetic abnormalities Women with uterine anomalies Women with uterine surgical history Women with endometriosis and adenomyosis Women with hydrosalpinx Women with uterine fibroids Early (day 3) follicular phase follicle stimulating hormone levels ≥12 IU/L Severe male factor infertility (azoospermia) Surrogate mothers Embryo donation N97.9 Female infertility, unspecified Treatment - Other Treatment - Other Intervention group: The group of endometrial preparation with gonadotropin-releasing hormone agonist. In this group, the endometrium of patients for embryo transfer will be prepared through the standard protocol using a gonadotropin-releasing hormone agonist. This group has pituitary suppression prior to steroid hormone administration. Pituitary suppression in patients will be performed using 500 micro-gram suprefact (Buserelin, Sanofi Aventis, Germany) injection per day subcutaneously from day 17 of the menstrual and continued it for 14 days. Then, the dose of suprefact was reduced to 200 micro-gram per day, and the endometrium will be prepared through daily administration of 6 mg of estradiol valerate tablets (Abouryhan Pharmacy Company, Tehran, Iran) for 12 days. When endometrial thickness reached 8 mm or more, 50 mg intramuscular progesterone (Abouryhan Pharmacy Company, Tehran, Iran) daily will be commenced, and suprefact will be stopped. Embryo transfer will be performed at 48±3 hours after progesterone injection for two day embryos and 72±3 hours after progesterone injection for three day embryos. Control group: The group of endometrial preparation without gonadotropin-releasing hormone agonist. In this group, the endometrium of patients for embryo transfer will be prepared through the standard protocol using steroid hormone administration without gonadotropin-releasing hormone agonist. This group begins steroid supplementation without prior pituitary desensitization. The endometrium will be prepared through daily administration of 6 mg of estradiol valerate tablets (Abouryhan Pharmacy Company, Tehran, Iran) for 12 days. When endometrial thickness reached 8 mm or more, 50 mg intramuscular progesterone (Abouryhan Pharmacy Company, Tehran, Iran) daily will be commenced. Embryo transfer will be performed at 48±3 hours after progesterone injection for two day embryos and 72±3 hours after progesterone injection for three day embryos. Live birth rate; live birth is defined in which a live fetus is delivered beyond 20 completed weeks of gestational. Timepoint: Only once; at least 20 weeks after embryo transfer. Method of measurement: Clinical information. ROYAN Institute Approved 2017-08-15 Ethics Committee of Royan Institute Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway. Tehran Tehran Iran (Islamic Republic of)