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IRCT20080831001141N33 IRCT 2021-01-01 Royan Institute Comparison of Two Ovarian Stimulation Protocols in Polycystic Ovarian Syndrome (PCOS) Patients Undergoing IVF/ICSI IVF/ICSI, BMI, PCOS,TESE-PESA Comparison of Ovarian Stimulation Cycle Outcome in Medroxy Progesterone Acetate and Gonadotropin Protocol with Antagonist and Gonadotropin Protocol in Polycystic Ovarian Syndrome Patients Undergoing In-Vitro fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI) 2019-05-28 anticipated 232 Complete https://irct.ir/trial/53232 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is designed by epidemiologist using randomization website and the number of blocks considered is 4. As soon as the patient is entered into the study, the treatment code is determined from the randomly generated sequence and a unique identification code is assigned to the patient. Random codes are stored in the main project management unit of the study and are inqueried through the clinical caregiver and the relevant intervention will be applied to the new patient. For this purpose, after determining the patient eligibility, the clinical caregiver, inquiries from the project management unit and announces the patient information and receives the patient's assigned identification and treatment code. Therefore, the clinical caregiver will not be aware of the allocative treatment until the patient is admitted. N/A Polycystic ovarian syndrome. Intervention 1: Intervention group: Patients will receive rFSH (with or without HMG) at a dose of 150 to 225 IU/day and MPA 10 mg/day from day 3 of menstruation. Intervention 2: Control group: Patients will receive rFSH (with or without HMG) at a dose of 150 to 225 IU/day from day 3 of menstruation and GnRH antagonist (cetrotide 0.25mg) is administered. 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 There is no more information
public Parisa Mostafaei
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway
Tehran Iran (Islamic Republic of) 1665659911 +98 21 2356 2645 mostafaeip@yahoo.com Royan Institute scientific Marzieh Shiva
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway
Tehran Iran (Islamic Republic of) 1665659911 +98 21 2356 2645 shivamarzieh@yahoo.com Royan Institute Iran (Islamic Republic of) The major criteria for diagnosis of PCOS are oligo and/or anovulation, clinical or biochemical signs of hyperandrogenism and polycystic ovaries; these criteria are in accordance with the revised 2003 Rotterdam criteria for PCOS Age between 18 to 39 years Body mass Index (BMI) less than 30 kg/m2 18 years 39 years Female Clinically significant systemic disease such as renal failure Endometriosis grade 3 or higher Received hormonal treatments in the previous 3 months Any contraindications to ovarian stimulation Sever male factor (TESE-PESA) E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Patients will receive rFSH (with or without HMG) at a dose of 150 to 225 IU/day and MPA 10 mg/day from day 3 of menstruation. Control group: Patients will receive rFSH (with or without HMG) at a dose of 150 to 225 IU/day from day 3 of menstruation and GnRH antagonist (cetrotide 0.25mg) is administered. Fertilization rate. Timepoint: 16-18 hours after sperm insemination or injection. Method of measurement: The ratio between the number of zygotes with two pronucleus and the injected oocytes. Quality of retrieved oocytes including GV, MI, MII. Timepoint: Immediately after oocyte puncture. Method of measurement: GV: Germinal vesicle present in the ooplasm; MI: No visible GV in the ooplasm and no first polar body in the perivitelline space; MII: Small perivitelline space containing a single unfragmented first polar body. Number of MII oocytes. Timepoint: Immediately after oocyte puncture. Method of measurement: Observation of oocytes that were mature at the time of oocyte collection. OHSS occurrence. Timepoint: From puncture to subsequent mensturation. Method of measurement: Classification system according to the Navot scheme, including mild, moderate and severe forms. Premature LH surge. Timepoint: During ovarian stimulation until the day of triggering. Method of measurement: Serum LH level of equally or more than 10 mIU or an increase of more than 2.5 times above the basal level. Clinical pregnancy. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG. Cumulative live birth rate. Timepoint: Delivery of a live fetus after the 24th week of pregnancy with vital activity. Method of measurement: The sum of live birth events resulting from embryo transfers following an ovarian stimulation cycle performed in the study, divided by the number of patients in each group. The rates of obstetrics complications including gestational diabetes, preeclampsia and preterm birth. Timepoint: 20 to 42 weeks of pregnancy. Method of measurement: Diagnosed cases of gestational diabetes, preeclampsia, and preterm labor will be followed up and recorded by a gynecologist during pregnancy in all patients. Neonatal outcomes. Timepoint: At birth and a week later. Method of measurement: The neonatologist will evaluate the gestational age, baby's sex, birth weight, presence of congenital abnormalities, diagnosis of respiratory distress syndrome, and diagnosis of jaundice within the first week of birth. The details regarding the newborn will be documented and monitored through phone follow-ups. Royan Institute Approved 2019-05-28 Ethics committee of Royan Institute Number 12, East Hafez Avenue, Bani Hashem Street, Resalat Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)